Trial Outcomes & Findings for A Study of PVP001, PVP002, and PVP003 in Healthy Adults and PVP001 and PVP002 in Adults With Celiac Disease (NCT NCT03701555)
NCT ID: NCT03701555
Last Updated: 2023-04-04
Results Overview
Median percentage degraded relative to placebo was derived using the formula: (1 - \[active/placebo\])\*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
139 participants
Primary outcome timeframe
Cohort Treatment Day: at 35 minutes post-dose
Results posted on
2023-04-04
Participant Flow
Participants took part in this study at 1 investigative site in the United States from 19 June 2018 to 02 July 2021.
Healthy participants and participants with Celiac Disease (CeD) were enrolled in this 4-part study. In Part 1, healthy participants and participants with CeD were enrolled and in Parts 2, 3 and 4 only healthy participants were enrolled to receive PVP001 (TAK-062 liquid), PVP002 (TAK-062 capsule), and PVP003 (TAK-062 tablet) formulation or matching-placebo.
Participant milestones
| Measure |
Part 1, (1A-1): PvP001 Placebo
PvP001 (TAK-062 liquid formulation) placebo-matching liquid, orally, single dose on Cohort Treatment Day in healthy participants.
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Part 1, (1B-1): PvP001 100 mg
PvP001 (TAK-062 liquid formulation) 100 milligram (mg), orally, single dose on Cohort Treatment Day in healthy participants.
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Part 1, (1C-1): PvP001 300 mg
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in healthy participants.
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Part 1, (1D-1): PvP001 900 mg
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in healthy participants.
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Part 1, (1E-1): PvP002 600 mg
PvP002 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in healthy participants.
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Part 1, (1A-2): PvP001 Placebo
PvP001 (TAK-062 liquid formulation) placebo-matching liquid, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 1, (1B-2): PvP001 100 mg
PvP001 (TAK-062 liquid formulation) 100 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 1, (1C-2): PvP001 300 mg
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 1, (1D-2): PvP001 900 mg
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 1, (1E-2): PvP002 600 mg
PvP002 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 2, Group 1: PvP001 Placebo (2A) + PvP001 900 mg (2B) + PvP001 900 mg With PPI (2C)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 900 mg following 7 days of proton pump inhibitor (PPI) treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 1: PvP001 Placebo (2A) + PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, PvP001 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C further followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 1: PvP001 900 mg (2B) + PvP001 Placebo (2A) + PvP001 900 mg With PPI (2C)
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, further followed by PvP001 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 1: PvP001 900 mg (2B) + PvP001 900 mg With PPI (2C) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, further followed by PvP001 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 Placebo (2A) + PvP001 900 mg (2B)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, further followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 3, Group 1: PvP003 Placebo (3A) + PvP003 600 mg (3B)
PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3A) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3A, followed by PvP003 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
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Part 3, Group 1: PvP003 600 mg (3B) + PvP003 Placebo (3A)
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B, followed by PvP003 placebo-matching tablet (3A) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3A in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
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Part 3, Group 2: PvP003 Placebo (3C) + PvP003 600 mg (3D)
PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3C) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3C, followed by PvP003 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
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Part 3, Group 2: PvP003 600 mg (3D) + PvP003 Placebo (3C)
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D, followed by PvP003 placebo-matching tablet (3C) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3C in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
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Part 3, Group 3: PvP003 Placebo (3E) + PvP003 600 mg (3F)
PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3E) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003 orally, single dose on Cohort Treatment Day of Cohort 3E, followed by PvP003 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003 orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
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Part 3, Group 3: PvP003 600 mg (3F) + PvP003 Placebo (3E)
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003 orally, single dose on Cohort Treatment Day of Cohort 3F, followed by PvP003 placebo-matching tablet (3E) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3E, in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
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Part 3, Group 4: PvP003 Placebo (3G) + PvP003 600 mg (3H)
PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3G) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3G, followed by PvP003 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
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Part 3, Group 4: PvP003 600 mg (3H) + PvP003 Placebo (3G)
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H, followed by PvP003 placebo-matching tablet (3G) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3G, in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
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Part 3, Group 5: PvP003 Placebo (3I) + PvP003 150 mg (3J)
PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3I) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3I, followed by PvP003 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
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Part 3, Group 5: PvP003 150 mg (3J) + PvP003 Placebo (3I)
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J, followed by PvP003 placebo-matching tablet (3I) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3I in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
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Part 4: PvP003 Placebo, TID (4A) + PvP003 600 mg, TID (4B)
PvP003 (TAK-062 tablet formulation) placebo-matching tablet, administered as two tablets of PvP003 placebo, orally, thrice a day (TID) on Treatment Days 1 to 5 (4A) of Cohort Treatment Period 1, followed by PvP003 600 mg administered as two tablets of PvP003 300 mg, orally, TID on Treatment Days 1 to 5 (4B) of Cohort Treatment Period 2 in healthy participants. There was a washout period of 3 days between the two Cohort Treatment Periods.
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Part 4: PvP003 600 mg, TID (4B) + PvP003 Placebo, TID (4A)
PvP003 (TAK-062 tablet formulation) 600 mg, administered as two tablets of PvP003 300 mg, orally, TID on Treatment Days 1 to 5 (4B) of Cohort Treatment Period 1, followed by PvP003 placebo-matching tablet, administered as two tablets of PvP003 placebo, orally, TID on Treatment Days 1 to 5 (4A) of Cohort Treatment Period 2 in healthy participants. There was a washout period of 3 days between the two Cohort Treatment Periods.
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Part 1 (Day 1)
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Part 4, Washout Period (3 Days)
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Part 4, Washout Period (3 Days)
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 4, Period 2 (Days 1 to 5)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
|
0
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0
|
0
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0
|
0
|
0
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0
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0
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0
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0
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0
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0
|
0
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0
|
0
|
0
|
0
|
3
|
3
|
|
Part 4, Period 2 (Days 1 to 5)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
0
|
0
|
0
|
0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
|
Part 4, Period 2 (Days 1 to 5)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1, (1A-1): PvP001 Placebo
PvP001 (TAK-062 liquid formulation) placebo-matching liquid, orally, single dose on Cohort Treatment Day in healthy participants.
|
Part 1, (1B-1): PvP001 100 mg
PvP001 (TAK-062 liquid formulation) 100 milligram (mg), orally, single dose on Cohort Treatment Day in healthy participants.
|
Part 1, (1C-1): PvP001 300 mg
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in healthy participants.
|
Part 1, (1D-1): PvP001 900 mg
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in healthy participants.
|
Part 1, (1E-1): PvP002 600 mg
PvP002 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in healthy participants.
|
Part 1, (1A-2): PvP001 Placebo
PvP001 (TAK-062 liquid formulation) placebo-matching liquid, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1B-2): PvP001 100 mg
PvP001 (TAK-062 liquid formulation) 100 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1C-2): PvP001 300 mg
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1D-2): PvP001 900 mg
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1E-2): PvP002 600 mg
PvP002 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 2, Group 1: PvP001 Placebo (2A) + PvP001 900 mg (2B) + PvP001 900 mg With PPI (2C)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 900 mg following 7 days of proton pump inhibitor (PPI) treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 1: PvP001 Placebo (2A) + PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, PvP001 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C further followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 1: PvP001 900 mg (2B) + PvP001 Placebo (2A) + PvP001 900 mg With PPI (2C)
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, further followed by PvP001 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 1: PvP001 900 mg (2B) + PvP001 900 mg With PPI (2C) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, further followed by PvP001 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 Placebo (2A) + PvP001 900 mg (2B)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, further followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 3, Group 1: PvP003 Placebo (3A) + PvP003 600 mg (3B)
PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3A) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3A, followed by PvP003 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
|
Part 3, Group 1: PvP003 600 mg (3B) + PvP003 Placebo (3A)
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B, followed by PvP003 placebo-matching tablet (3A) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3A in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
|
Part 3, Group 2: PvP003 Placebo (3C) + PvP003 600 mg (3D)
PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3C) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3C, followed by PvP003 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
|
Part 3, Group 2: PvP003 600 mg (3D) + PvP003 Placebo (3C)
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D, followed by PvP003 placebo-matching tablet (3C) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3C in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
|
Part 3, Group 3: PvP003 Placebo (3E) + PvP003 600 mg (3F)
PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3E) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003 orally, single dose on Cohort Treatment Day of Cohort 3E, followed by PvP003 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003 orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
|
Part 3, Group 3: PvP003 600 mg (3F) + PvP003 Placebo (3E)
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003 orally, single dose on Cohort Treatment Day of Cohort 3F, followed by PvP003 placebo-matching tablet (3E) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3E, in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
|
Part 3, Group 4: PvP003 Placebo (3G) + PvP003 600 mg (3H)
PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3G) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3G, followed by PvP003 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
|
Part 3, Group 4: PvP003 600 mg (3H) + PvP003 Placebo (3G)
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H, followed by PvP003 placebo-matching tablet (3G) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3G, in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
|
Part 3, Group 5: PvP003 Placebo (3I) + PvP003 150 mg (3J)
PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3I) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3I, followed by PvP003 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
|
Part 3, Group 5: PvP003 150 mg (3J) + PvP003 Placebo (3I)
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J, followed by PvP003 placebo-matching tablet (3I) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3I in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
|
Part 4: PvP003 Placebo, TID (4A) + PvP003 600 mg, TID (4B)
PvP003 (TAK-062 tablet formulation) placebo-matching tablet, administered as two tablets of PvP003 placebo, orally, thrice a day (TID) on Treatment Days 1 to 5 (4A) of Cohort Treatment Period 1, followed by PvP003 600 mg administered as two tablets of PvP003 300 mg, orally, TID on Treatment Days 1 to 5 (4B) of Cohort Treatment Period 2 in healthy participants. There was a washout period of 3 days between the two Cohort Treatment Periods.
|
Part 4: PvP003 600 mg, TID (4B) + PvP003 Placebo, TID (4A)
PvP003 (TAK-062 tablet formulation) 600 mg, administered as two tablets of PvP003 300 mg, orally, TID on Treatment Days 1 to 5 (4B) of Cohort Treatment Period 1, followed by PvP003 placebo-matching tablet, administered as two tablets of PvP003 placebo, orally, TID on Treatment Days 1 to 5 (4A) of Cohort Treatment Period 2 in healthy participants. There was a washout period of 3 days between the two Cohort Treatment Periods.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2 (Day 1)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 (Day 1)
Subject Non-compliance
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 (Day 1)
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
0
|
1
|
0
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3 (Day 1)
Subject Non-compliance
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part 3 (Day 1)
Subject Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
2
|
1
|
1
|
0
|
0
|
|
Part 3 (Day 1)
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
1
|
0
|
0
|
Baseline Characteristics
A Study of PVP001, PVP002, and PVP003 in Healthy Adults and PVP001 and PVP002 in Adults With Celiac Disease
Baseline characteristics by cohort
| Measure |
Part 1, (1A-1): PvP001 Placebo
n=3 Participants
PvP001 (TAK-062 liquid formulation) placebo-matching liquid, orally, single dose on Cohort Treatment Day in healthy participants.
|
Part 1, (1B-1): PvP001 100 mg
n=3 Participants
PvP001 (TAK-062 liquid formulation) 100 mg, orally, single dose on Cohort Treatment Day in healthy participants.
|
Part 1, (1C-1): PvP001 300 mg
n=3 Participants
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in healthy participants.
|
Part 1, (1D-1): PvP001 900 mg
n=3 Participants
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in healthy participants.
|
Part 1, (1E-1): PvP002 600 mg
n=3 Participants
PvP002 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in healthy participants.
|
Part 1, (1A-2): PvP001 Placebo
n=3 Participants
PvP001 (TAK-062 liquid formulation) placebo-matching liquid, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1B-2): PvP001 100 mg
n=3 Participants
PvP001 (TAK-062 liquid formulation) 100 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1C-2): PvP001 300 mg
n=3 Participants
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1D-2): PvP001 900 mg
n=3 Participants
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1E-2): PvP002 600 mg
n=1 Participants
PvP002 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 2, Group 1: PvP001 Placebo (2A) + PvP001 900 mg (2B) + PvP001 900 mg With PPI (2C)
n=3 Participants
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 1: PvP001 Placebo (2A) + PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B)
n=3 Participants
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, PvP001 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C further followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 1: PvP001 900 mg (2B) + PvP001 Placebo (2A) + PvP001 900 mg With PPI (2C)
n=2 Participants
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, further followed by PvP001 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 1: PvP001 900 mg (2B) + PvP001 900 mg With PPI (2C) + PvP001 Placebo (2A)
n=2 Participants
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, further followed by PvP001 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 Placebo (2A) + PvP001 900 mg (2B)
n=2 Participants
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A, further followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
n=2 Participants
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
n=4 Participants
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
n=5 Participants
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
n=4 Participants
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
n=4 Participants
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
n=4 Participants
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
n=4 Participants
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
n=4 Participants
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
n=4 Participants
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 3, Group 1: PvP003 Placebo (3A) + PvP003 600 mg (3B)
n=3 Participants
PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3A) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3A, followed by PvP003 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
|
Part 3, Group 1: PvP003 600 mg (3B) + PvP003 Placebo (3A)
n=4 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B, followed by PvP003 placebo-matching tablet (3A) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3A in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
|
Part 3, Group 2: PvP003 Placebo (3C) + PvP003 600 mg (3D)
n=1 Participants
PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3C) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3C, followed by PvP003 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
|
Part 3, Group 2: PvP003 600 mg (3D) + PvP003 Placebo (3C)
n=5 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D, followed by PvP003 placebo-matching tablet (3C) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3C in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
|
Part 3, Group 3: PvP003 Placebo (3E) + PvP003 600 mg (3F)
n=3 Participants
PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3E) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003 orally, single dose on Cohort Treatment Day of Cohort 3E, followed by PvP003 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003 orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
|
Part 3, Group 3: PvP003 600 mg (3F) + PvP003 Placebo (3E)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003 orally, single dose on Cohort Treatment Day of Cohort 3F, followed by PvP003 placebo-matching tablet (3E) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3E, in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
|
Part 3, Group 4: PvP003 Placebo (3G) + PvP003 600 mg (3H)
n=3 Participants
PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3G) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3G, followed by PvP003 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
|
Part 3, Group 4: PvP003 600 mg (3H) + PvP003 Placebo (3G)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H, followed by PvP003 placebo-matching tablet (3G) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3G, in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
|
Part 3, Group 5: PvP003 Placebo (3I) + PvP003 150 mg (3J)
n=5 Participants
PvP003 (TAK-062 tablet formulation) placebo-matching tablet (3I) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3I, followed by PvP003 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
|
Part 3, Group 5: PvP003 150 mg (3J) + PvP003 Placebo (3I)
n=8 Participants
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J, followed by PvP003 placebo-matching tablet (3I) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3I in healthy participants. There was a washout period of 3 days between each Cohort Treatment Day.
|
Part 4: PvP003 Placebo, TID (4A) + PvP003 600 mg, TID (4B)
n=3 Participants
PvP003 (TAK-062 tablet formulation) placebo-matching tablet, administered as two tablets of PvP003 placebo, orally, TID on Treatment Days 1 to 5 (4A) of Cohort Treatment Period 1, followed by PvP003 600 mg administered as two tablets of PvP003 300 mg, orally, TID on Treatment Days 1 to 5 (4B) of Cohort Treatment Period 2 in healthy participants. There was a washout period of 3 days between the two Cohort Treatment Periods.
|
Part 4: PvP003 600 mg, TID (4B) + PvP003 Placebo, TID (4A)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 600 mg, administered as two tablets of PvP003 300 mg, orally, TID on Treatment Days 1 to 5 (4B) of Cohort Treatment Period 1, followed by PvP003 placebo-matching tablet, administered as two tablets of PvP003 placebo, orally, TID on Treatment Days 1 to 5 (4A) of Cohort Treatment Period 2 in healthy participants. There was a washout period of 3 days between the two Cohort Treatment Periods.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=119 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
4 Participants
n=136 Participants
|
5 Participants
n=44 Participants
|
4 Participants
n=667 Participants
|
4 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
4 Participants
n=11 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=408 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=16 Participants
|
3 Participants
n=252 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=269 Participants
|
8 Participants
n=23 Participants
|
3 Participants
n=116 Participants
|
3 Participants
n=3 Participants
|
119 Participants
n=119 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=119 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
3 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
1 Participants
n=11 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=408 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=252 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=269 Participants
|
2 Participants
n=23 Participants
|
0 Participants
n=116 Participants
|
1 Participants
n=3 Participants
|
44 Participants
n=119 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
4 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
3 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=408 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=16 Participants
|
2 Participants
n=252 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=269 Participants
|
6 Participants
n=23 Participants
|
3 Participants
n=116 Participants
|
2 Participants
n=3 Participants
|
75 Participants
n=119 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
3 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=408 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=252 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=269 Participants
|
2 Participants
n=23 Participants
|
2 Participants
n=116 Participants
|
0 Participants
n=3 Participants
|
33 Participants
n=119 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
4 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
4 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
3 Participants
n=11 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=408 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=16 Participants
|
2 Participants
n=252 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=269 Participants
|
6 Participants
n=23 Participants
|
1 Participants
n=116 Participants
|
3 Participants
n=3 Participants
|
86 Participants
n=119 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=119 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=119 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=269 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=116 Participants
|
1 Participants
n=3 Participants
|
11 Participants
n=119 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=119 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=11 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=16 Participants
|
2 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=269 Participants
|
4 Participants
n=23 Participants
|
1 Participants
n=116 Participants
|
0 Participants
n=3 Participants
|
32 Participants
n=119 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
4 Participants
n=667 Participants
|
3 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
2 Participants
n=11 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=408 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=16 Participants
|
1 Participants
n=252 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=269 Participants
|
3 Participants
n=23 Participants
|
2 Participants
n=116 Participants
|
2 Participants
n=3 Participants
|
75 Participants
n=119 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=119 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=269 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=119 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
4 Participants
n=136 Participants
|
5 Participants
n=44 Participants
|
4 Participants
n=667 Participants
|
4 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
4 Participants
n=11 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=408 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=16 Participants
|
3 Participants
n=252 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=269 Participants
|
8 Participants
n=23 Participants
|
3 Participants
n=116 Participants
|
3 Participants
n=3 Participants
|
119 Participants
n=119 Participants
|
PRIMARY outcome
Timeframe: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7)Population: Safety population included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed only for Part 1 of the study.
Outcome measures
| Measure |
Part 3, Group 4: PvP003 600 mg (3H)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
|
Part 3, Group 5: PvP003 150 mg (3J)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
|
Part 3, Group 1: PvP003 600 mg (3B)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
|
Part 3, Group 2: PvP003 600 mg (3D)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
|
Part 3, Group 3: PvP003 600 mg (3F)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
|
Part 1, (1C-2): PvP001 300 mg
n=3 Participants
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1D-2): PvP001 900 mg
n=3 Participants
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1E-2): PvP002 600 mg
n=3 Participants
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 2, Group 1: PvP001 900 mg (2B)
n=3 Participants
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C)
n=1 Participants
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
|
Part 2, Group 2: PvP002 Placebo (2D)
PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
|
Part 2, Group 2: PvP002 600 mg (2E)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
|
Part 2, Group 3: PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
|
Part 2, Group 3: PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
|
Part 2, Group 3: PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) for PvP001 and PvP002
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up to Day 28)Population: Safety population included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed only for Part 4 of the study.
Outcome measures
| Measure |
Part 3, Group 4: PvP003 600 mg (3H)
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
|
Part 3, Group 5: PvP003 150 mg (3J)
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
|
Part 3, Group 1: PvP003 600 mg (3B)
n=6 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
|
Part 3, Group 2: PvP003 600 mg (3D)
n=6 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
|
Part 3, Group 3: PvP003 600 mg (3F)
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
|
Part 1, (1C-2): PvP001 300 mg
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1D-2): PvP001 900 mg
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1E-2): PvP002 600 mg
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 2, Group 1: PvP001 900 mg (2B)
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
|
Part 2, Group 2: PvP002 Placebo (2D)
PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
|
Part 2, Group 2: PvP002 600 mg (2E)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
|
Part 2, Group 3: PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
|
Part 2, Group 3: PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
|
Part 2, Group 3: PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 4: Number of Participants Reporting One or More TEAEs for PvP003 After Multiple Doses
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7)Population: Safety population included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed only for Part 1 of the study.
Outcome measures
| Measure |
Part 3, Group 4: PvP003 600 mg (3H)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
|
Part 3, Group 5: PvP003 150 mg (3J)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
|
Part 3, Group 1: PvP003 600 mg (3B)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
|
Part 3, Group 2: PvP003 600 mg (3D)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
|
Part 3, Group 3: PvP003 600 mg (3F)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
|
Part 1, (1C-2): PvP001 300 mg
n=3 Participants
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1D-2): PvP001 900 mg
n=3 Participants
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1E-2): PvP002 600 mg
n=3 Participants
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 2, Group 1: PvP001 900 mg (2B)
n=3 Participants
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C)
n=1 Participants
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
|
Part 2, Group 2: PvP002 Placebo (2D)
PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
|
Part 2, Group 2: PvP002 600 mg (2E)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
|
Part 2, Group 3: PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
|
Part 2, Group 3: PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
|
Part 2, Group 3: PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Part 1: Number of Participants Reporting One or More Treatment Emergent Serious Adverse Events (TESAEs) for PvP001 and PvP002
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
PRIMARY outcome
Timeframe: Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up to Day 28)Population: Safety population included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed only for Part 4 of the study.
Outcome measures
| Measure |
Part 3, Group 4: PvP003 600 mg (3H)
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
|
Part 3, Group 5: PvP003 150 mg (3J)
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
|
Part 3, Group 1: PvP003 600 mg (3B)
n=6 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
|
Part 3, Group 2: PvP003 600 mg (3D)
n=6 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
|
Part 3, Group 3: PvP003 600 mg (3F)
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
|
Part 1, (1C-2): PvP001 300 mg
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1D-2): PvP001 900 mg
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1E-2): PvP002 600 mg
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 2, Group 1: PvP001 900 mg (2B)
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
|
Part 2, Group 2: PvP002 Placebo (2D)
PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
|
Part 2, Group 2: PvP002 600 mg (2E)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
|
Part 2, Group 3: PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
|
Part 2, Group 3: PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
|
Part 2, Group 3: PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 4: Number of Participants Reporting One or More TESAEs for PvP003 600 mg After Multiple Doses
|
—
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—
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0 Participants
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0 Participants
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: Cohort Treatment DayPopulation: Intent-to-Treat (ITT) population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 1, Cohort 2B (PvP001 900 mg) of Part 2 only. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure.
Median percentage degraded relative to placebo was derived using the formula: (1 - \[active/placebo\])\*100. Gluten degradation was assessed using Enzyme-Linked Immunosorbent Assay (ELISA) based on the monoclonal R5 and G12 antibodies.
Outcome measures
| Measure |
Part 3, Group 4: PvP003 600 mg (3H)
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
|
Part 3, Group 5: PvP003 150 mg (3J)
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
|
Part 3, Group 1: PvP003 600 mg (3B)
n=11 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
|
Part 3, Group 2: PvP003 600 mg (3D)
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
|
Part 3, Group 3: PvP003 600 mg (3F)
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
|
Part 1, (1C-2): PvP001 300 mg
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1D-2): PvP001 900 mg
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1E-2): PvP002 600 mg
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 2, Group 1: PvP001 900 mg (2B)
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
|
Part 2, Group 2: PvP002 Placebo (2D)
PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
|
Part 2, Group 2: PvP002 600 mg (2E)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
|
Part 2, Group 3: PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
|
Part 2, Group 3: PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
|
Part 2, Group 3: PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Part 2, Group 1, Cohort 2B: Median Percentage of Gluten Degradation by PvP001 in a Standardized 3 Gram (gm) Gluten-containing Study Meal After Administration of PvP001
R5
|
—
|
—
|
94.41 percentage of gluten degradation
Interval 79.7 to 99.9
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Part 2, Group 1, Cohort 2B: Median Percentage of Gluten Degradation by PvP001 in a Standardized 3 Gram (gm) Gluten-containing Study Meal After Administration of PvP001
G12
|
—
|
—
|
97.89 percentage of gluten degradation
Interval 79.6 to 99.9
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
PRIMARY outcome
Timeframe: Cohort Treatment DayPopulation: ITT population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 2, Cohort 2E (PvP002 600 mg) of Part 2 only. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure.
Median percentage degraded relative to placebo was derived using the formula: (1 - \[active/placebo\])\*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Outcome measures
| Measure |
Part 3, Group 4: PvP003 600 mg (3H)
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
|
Part 3, Group 5: PvP003 150 mg (3J)
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
|
Part 3, Group 1: PvP003 600 mg (3B)
n=9 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
|
Part 3, Group 2: PvP003 600 mg (3D)
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
|
Part 3, Group 3: PvP003 600 mg (3F)
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
|
Part 1, (1C-2): PvP001 300 mg
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1D-2): PvP001 900 mg
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1E-2): PvP002 600 mg
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 2, Group 1: PvP001 900 mg (2B)
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
|
Part 2, Group 2: PvP002 Placebo (2D)
PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
|
Part 2, Group 2: PvP002 600 mg (2E)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
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Part 2, Group 3: PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
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Part 2, Group 3: PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
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Part 2, Group 3: PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
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Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 2, Cohort 2E: Median Percentage of Gluten Degradation by PvP002 in a Standardized 3 gm Gluten-containing Study Meal After Administration of PvP002
R5
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—
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—
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99.67 percentage of gluten degradation
Interval 0.0 to 99.8
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Part 2, Group 2, Cohort 2E: Median Percentage of Gluten Degradation by PvP002 in a Standardized 3 gm Gluten-containing Study Meal After Administration of PvP002
G12
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—
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—
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99.70 percentage of gluten degradation
Interval 0.0 to 99.9
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PRIMARY outcome
Timeframe: Cohort Treatment DayPopulation: ITT population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 1, Cohort 2C (PvP001 900 mg) of Part 2 only. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure.
Median percentage degraded relative to placebo was derived using the formula: (1 - \[active/placebo\])\*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Outcome measures
| Measure |
Part 3, Group 4: PvP003 600 mg (3H)
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
|
Part 3, Group 5: PvP003 150 mg (3J)
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
|
Part 3, Group 1: PvP003 600 mg (3B)
n=12 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
|
Part 3, Group 2: PvP003 600 mg (3D)
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
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Part 3, Group 3: PvP003 600 mg (3F)
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
|
Part 1, (1C-2): PvP001 300 mg
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 1, (1D-2): PvP001 900 mg
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 1, (1E-2): PvP002 600 mg
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 2, Group 1: PvP001 900 mg (2B)
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
|
Part 2, Group 2: PvP002 Placebo (2D)
PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
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Part 2, Group 2: PvP002 600 mg (2E)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
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Part 2, Group 3: PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
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Part 2, Group 3: PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
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Part 2, Group 3: PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
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Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 1, Cohort 2C: Median Percentage of Gluten Degradation by PvP001 in a Standardized 3 gm Gluten-containing Study Meal Following 7 Days of Standard Dose PPI Treatment
R5
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—
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—
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99.44 percentage of gluten degradation
Interval 92.3 to 99.9
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—
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—
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Part 2, Group 1, Cohort 2C: Median Percentage of Gluten Degradation by PvP001 in a Standardized 3 gm Gluten-containing Study Meal Following 7 Days of Standard Dose PPI Treatment
G12
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—
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—
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99.62 percentage of gluten degradation
Interval 97.6 to 99.8
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PRIMARY outcome
Timeframe: Cohort Treatment Day: at 20 minutes post-dosePopulation: ITT population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 3, Cohort 2G (PvP001 300 mg) and Cohort 2H (PvP001 600 mg) of Part 2 only.
Median percentage degraded relative to placebo was derived using the formula: (1 - \[active/placebo\])\*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Outcome measures
| Measure |
Part 3, Group 4: PvP003 600 mg (3H)
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
|
Part 3, Group 5: PvP003 150 mg (3J)
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
|
Part 3, Group 1: PvP003 600 mg (3B)
n=8 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
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Part 3, Group 2: PvP003 600 mg (3D)
n=8 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
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Part 3, Group 3: PvP003 600 mg (3F)
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
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Part 1, (1C-2): PvP001 300 mg
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 1, (1D-2): PvP001 900 mg
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 1, (1E-2): PvP002 600 mg
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 2, Group 1: PvP001 900 mg (2B)
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
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Part 2, Group 1: PvP001 900 mg With PPI (2C)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
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Part 2, Group 2: PvP002 Placebo (2D)
PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
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Part 2, Group 2: PvP002 600 mg (2E)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
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Part 2, Group 3: PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
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Part 2, Group 3: PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
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Part 2, Group 3: PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
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Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Part 2, Group 3, Cohort 2G and 2H: Median Percentage of Gluten Degradation by PvP001 300 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 20 Minutes After Administration of PvP001
R5: 20 minutes
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—
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—
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95.89 percentage of gluten degradation
Interval 55.6 to 99.2
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98.13 percentage of gluten degradation
Interval 95.0 to 99.9
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—
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Part 2, Group 3, Cohort 2G and 2H: Median Percentage of Gluten Degradation by PvP001 300 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 20 Minutes After Administration of PvP001
G12: 20 minutes
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—
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—
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97.63 percentage of gluten degradation
Interval 85.3 to 99.3
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97.98 percentage of gluten degradation
Interval 89.2 to 99.9
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PRIMARY outcome
Timeframe: Cohort Treatment Day: at 35 minutes post-dosePopulation: ITT population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 3, Cohort 2G (PvP001 300 mg) and Cohort 2H (PvP001 600 mg) of Part 2 only.
Median percentage degraded relative to placebo was derived using the formula: (1 - \[active/placebo\])\*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Outcome measures
| Measure |
Part 3, Group 4: PvP003 600 mg (3H)
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
|
Part 3, Group 5: PvP003 150 mg (3J)
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
|
Part 3, Group 1: PvP003 600 mg (3B)
n=8 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
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Part 3, Group 2: PvP003 600 mg (3D)
n=8 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
|
Part 3, Group 3: PvP003 600 mg (3F)
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
|
Part 1, (1C-2): PvP001 300 mg
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 1, (1D-2): PvP001 900 mg
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 1, (1E-2): PvP002 600 mg
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 2, Group 1: PvP001 900 mg (2B)
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
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Part 2, Group 1: PvP001 900 mg With PPI (2C)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
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Part 2, Group 2: PvP002 Placebo (2D)
PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
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Part 2, Group 2: PvP002 600 mg (2E)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
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Part 2, Group 3: PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
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Part 2, Group 3: PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
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Part 2, Group 3: PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
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Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3, Cohort 2G and 2H: Median Percentage of Gluten Degradation by PvP001 300 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 35 Minutes After Administration of PvP001
R5: 35 minutes
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—
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—
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98.19 percentage of gluten degradation
Interval 87.9 to 99.6
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98.95 percentage of gluten degradation
Interval 84.1 to 99.9
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Part 2, Group 3, Cohort 2G and 2H: Median Percentage of Gluten Degradation by PvP001 300 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 35 Minutes After Administration of PvP001
G12: 35 minutes
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—
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—
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97.92 percentage of gluten degradation
Interval 93.9 to 99.6
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98.43 percentage of gluten degradation
Interval 60.3 to 99.9
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PRIMARY outcome
Timeframe: Cohort Treatment Day: at 65 minutes post-dosePopulation: ITT population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 3, Cohort 2G (PvP001 300 mg) and Cohort 2H (PvP001 600 mg) of Part 2 only.
Median percentage degraded relative to placebo was derived using the formula: (1 - \[active/placebo\])\*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Outcome measures
| Measure |
Part 3, Group 4: PvP003 600 mg (3H)
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
|
Part 3, Group 5: PvP003 150 mg (3J)
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
|
Part 3, Group 1: PvP003 600 mg (3B)
n=8 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
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Part 3, Group 2: PvP003 600 mg (3D)
n=8 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
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Part 3, Group 3: PvP003 600 mg (3F)
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
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Part 1, (1C-2): PvP001 300 mg
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 1, (1D-2): PvP001 900 mg
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 1, (1E-2): PvP002 600 mg
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 2, Group 1: PvP001 900 mg (2B)
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
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Part 2, Group 1: PvP001 900 mg With PPI (2C)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
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Part 2, Group 2: PvP002 Placebo (2D)
PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
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Part 2, Group 2: PvP002 600 mg (2E)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
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Part 2, Group 3: PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
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Part 2, Group 3: PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
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Part 2, Group 3: PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
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Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Part 2, Group 3, Cohort 2G and 2H: Median Percentage of Gluten Degradation by PvP001 300 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 65 Minutes After Administration of PvP001
R5: 65 minutes
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—
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—
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95.21 percentage of gluten degradation
Interval 83.8 to 98.4
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98.15 percentage of gluten degradation
Interval 85.6 to 99.9
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Part 2, Group 3, Cohort 2G and 2H: Median Percentage of Gluten Degradation by PvP001 300 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 65 Minutes After Administration of PvP001
G12: 65 minutes
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—
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96.30 percentage of gluten degradation
Interval 86.8 to 99.5
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98.87 percentage of gluten degradation
Interval 82.1 to 99.9
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PRIMARY outcome
Timeframe: Cohort Treatment Day: at 20 minutes post-dosePopulation: ITT population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 3, Cohort 2J (PvP001 900 mg) of Part 2 only.
Median percentage degraded relative to placebo was derived using the formula: (1 - \[active/placebo\])\*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Outcome measures
| Measure |
Part 3, Group 4: PvP003 600 mg (3H)
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
|
Part 3, Group 5: PvP003 150 mg (3J)
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
|
Part 3, Group 1: PvP003 600 mg (3B)
n=8 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
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Part 3, Group 2: PvP003 600 mg (3D)
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
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Part 3, Group 3: PvP003 600 mg (3F)
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
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Part 1, (1C-2): PvP001 300 mg
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 1, (1D-2): PvP001 900 mg
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 1, (1E-2): PvP002 600 mg
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 2, Group 1: PvP001 900 mg (2B)
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
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Part 2, Group 1: PvP001 900 mg With PPI (2C)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
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Part 2, Group 2: PvP002 Placebo (2D)
PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
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Part 2, Group 2: PvP002 600 mg (2E)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
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Part 2, Group 3: PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
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Part 2, Group 3: PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
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Part 2, Group 3: PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
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Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Part 2, Group 3, Cohort 2J: Median Percentage of Gluten Degradation by PvP001 900 mg in a Standardized 6 gm Gluten-containing Study Meal at 20 Minutes After Administration of PvP001
R5: 20 minutes
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—
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—
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99.82 percentage of gluten degradation
Interval 62.2 to 100.0
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Part 2, Group 3, Cohort 2J: Median Percentage of Gluten Degradation by PvP001 900 mg in a Standardized 6 gm Gluten-containing Study Meal at 20 Minutes After Administration of PvP001
G12: 20 minutes
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—
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99.77 percentage of gluten degradation
Interval 85.2 to 99.9
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PRIMARY outcome
Timeframe: Cohort Treatment Day: at 35 minutes post-dosePopulation: ITT population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 3, Cohort 2J (PvP001 900 mg) of Part 2 only.
Median percentage degraded relative to placebo was derived using the formula: (1 - \[active/placebo\])\*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Outcome measures
| Measure |
Part 3, Group 4: PvP003 600 mg (3H)
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
|
Part 3, Group 5: PvP003 150 mg (3J)
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
|
Part 3, Group 1: PvP003 600 mg (3B)
n=8 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
|
Part 3, Group 2: PvP003 600 mg (3D)
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
|
Part 3, Group 3: PvP003 600 mg (3F)
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
|
Part 1, (1C-2): PvP001 300 mg
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1D-2): PvP001 900 mg
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 1, (1E-2): PvP002 600 mg
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 2, Group 1: PvP001 900 mg (2B)
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
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Part 2, Group 1: PvP001 900 mg With PPI (2C)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
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Part 2, Group 2: PvP002 Placebo (2D)
PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
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Part 2, Group 2: PvP002 600 mg (2E)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
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Part 2, Group 3: PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
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Part 2, Group 3: PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
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Part 2, Group 3: PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
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Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3, Cohort 2J: Median Percentage of Gluten Degradation by PvP001 900 mg in a Standardized 6 gm Gluten-containing Study Meal at 35 Minutes After Administration of PvP001
R5: 35 minutes
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99.48 percentage of gluten degradation
Interval 97.0 to 99.9
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Part 2, Group 3, Cohort 2J: Median Percentage of Gluten Degradation by PvP001 900 mg in a Standardized 6 gm Gluten-containing Study Meal at 35 Minutes After Administration of PvP001
G12: 35 minutes
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99.69 percentage of gluten degradation
Interval 96.2 to 100.0
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PRIMARY outcome
Timeframe: Cohort Treatment Day: at 65 minutes post-dosePopulation: ITT population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 3, Cohort 2J (PvP001 900 mg) of Part 2 only.
Median percentage degraded relative to placebo was derived using the formula: (1 - \[active/placebo\])\*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Outcome measures
| Measure |
Part 3, Group 4: PvP003 600 mg (3H)
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
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Part 3, Group 5: PvP003 150 mg (3J)
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
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Part 3, Group 1: PvP003 600 mg (3B)
n=8 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
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Part 3, Group 2: PvP003 600 mg (3D)
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
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Part 3, Group 3: PvP003 600 mg (3F)
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
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Part 1, (1C-2): PvP001 300 mg
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 1, (1D-2): PvP001 900 mg
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 1, (1E-2): PvP002 600 mg
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 2, Group 1: PvP001 900 mg (2B)
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
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Part 2, Group 1: PvP001 900 mg With PPI (2C)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
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Part 2, Group 2: PvP002 Placebo (2D)
PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
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Part 2, Group 2: PvP002 600 mg (2E)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
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Part 2, Group 3: PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
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Part 2, Group 3: PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
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Part 2, Group 3: PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
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Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3, Cohort 2J: Median Percentage of Gluten Degradation by PvP001 900 mg in a Standardized 6 gm Gluten-containing Study Meal at 65 Minutes After Administration of PvP001
R5: 65 minutes
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—
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99.22 percentage of gluten degradation
Interval 87.8 to 100.0
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Part 2, Group 3, Cohort 2J: Median Percentage of Gluten Degradation by PvP001 900 mg in a Standardized 6 gm Gluten-containing Study Meal at 65 Minutes After Administration of PvP001
G12: 65 minutes
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—
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—
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98.49 percentage of gluten degradation
Interval 76.1 to 100.0
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PRIMARY outcome
Timeframe: Cohort Treatment Day: at 35 minutesPopulation: ITT population in Part 3 of study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed for Group 1, Cohort 3B (PvP003 600 mg), Group 2, Cohort 3D (PvP003 600 mg), Group 3, Cohort 3F (PvP003 600 mg), Group 4, Cohort 3H (PvP003 600 mg) and Group 5, Cohort 3J (PvP003 150 mg) of Part 3. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure.
Median percentage degraded relative to placebo was derived using the formula: (1 - \[active/placebo\])\*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Outcome measures
| Measure |
Part 3, Group 4: PvP003 600 mg (3H)
n=6 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
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Part 3, Group 5: PvP003 150 mg (3J)
n=12 Participants
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
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Part 3, Group 1: PvP003 600 mg (3B)
n=6 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
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Part 3, Group 2: PvP003 600 mg (3D)
n=6 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
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Part 3, Group 3: PvP003 600 mg (3F)
n=5 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
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Part 1, (1C-2): PvP001 300 mg
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 1, (1D-2): PvP001 900 mg
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 1, (1E-2): PvP002 600 mg
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
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Part 2, Group 1: PvP001 900 mg (2B)
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
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Part 2, Group 1: PvP001 900 mg With PPI (2C)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
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Part 2, Group 2: PvP002 Placebo (2D)
PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
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Part 2, Group 2: PvP002 600 mg (2E)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
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Part 2, Group 3: PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
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Part 2, Group 3: PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
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Part 2, Group 3: PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
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Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 3, Groups 1 to 5, Cohorts 3B, 3D, 3F, 3H and 3J: Median Percentage of Gluten Degradation by PvP003 150 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 35 Minutes After Administration of PvP003
R5: 35 minutes
|
NA percentage of gluten degradation
Data was not estimable due to gluten concentrations below the limit of quantification (LLOQ) of 10 microgram per milliliter (mcg/mL).
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88.23 percentage of gluten degradation
Interval -970.5 to 99.7
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94.68 percentage of gluten degradation
Interval 57.0 to 97.5
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79.69 percentage of gluten degradation
Interval -17.0 to 95.4
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68.49 percentage of gluten degradation
Interval 26.6 to 98.9
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Part 3, Groups 1 to 5, Cohorts 3B, 3D, 3F, 3H and 3J: Median Percentage of Gluten Degradation by PvP003 150 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 35 Minutes After Administration of PvP003
G12: 35 minutes
|
NA percentage of gluten degradation
Data was not estimable due to gluten concentrations below the limit of quantification (LLOQ) of 10 microgram per milliliter (mcg/mL).
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93.12 percentage of gluten degradation
Interval -554.2 to 99.7
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96.66 percentage of gluten degradation
Interval 73.5 to 99.2
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71.71 percentage of gluten degradation
Interval -24.5 to 96.5
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71.11 percentage of gluten degradation
Interval -200.0 to 96.0
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PRIMARY outcome
Timeframe: Cohort Treatment Day: at 65 minutesPopulation: ITT population in Part 3 of study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed for Group 1, Cohort 3B (PvP003 600 mg), Group 2, Cohort 3D (PvP003 600 mg), Group 3, Cohort 3F (PvP003 600 mg), Group 4,Cohort 3H (PvP003 600 mg), Group 5, Cohort 3J (PvP003 150 mg) of Part 3. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure.
Median percentage degraded relative to placebo was derived using the formula: (1 - \[active/placebo\])\*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies.
Outcome measures
| Measure |
Part 3, Group 4: PvP003 600 mg (3H)
n=6 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
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Part 3, Group 5: PvP003 150 mg (3J)
n=12 Participants
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
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Part 3, Group 1: PvP003 600 mg (3B)
n=6 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
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Part 3, Group 2: PvP003 600 mg (3D)
n=6 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
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Part 3, Group 3: PvP003 600 mg (3F)
n=5 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
|
Part 1, (1C-2): PvP001 300 mg
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1D-2): PvP001 900 mg
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1E-2): PvP002 600 mg
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 2, Group 1: PvP001 900 mg (2B)
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
|
Part 2, Group 2: PvP002 Placebo (2D)
PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
|
Part 2, Group 2: PvP002 600 mg (2E)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
|
Part 2, Group 3: PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
|
Part 2, Group 3: PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
|
Part 2, Group 3: PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Part 3, Groups 1 to 5, Cohorts 3B, 3D, 3F, 3H and 3J: Median Percentage of Gluten Degradation by PvP003 150 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 65 Minutes After Administration of PvP003
R5: 65 minutes
|
98.86 percentage of gluten degradation
Interval -252.0 to 99.8
|
84.48 percentage of gluten degradation
Interval -312.3 to 99.8
|
89.54 percentage of gluten degradation
Interval -1082.4 to 99.8
|
50.36 percentage of gluten degradation
Interval -149.1 to 95.1
|
85.63 percentage of gluten degradation
Interval 47.4 to 99.1
|
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Part 3, Groups 1 to 5, Cohorts 3B, 3D, 3F, 3H and 3J: Median Percentage of Gluten Degradation by PvP003 150 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 65 Minutes After Administration of PvP003
G12: 65 minutes
|
96.34 percentage of gluten degradation
Interval -224.1 to 98.6
|
92.35 percentage of gluten degradation
Interval -423.2 to 99.8
|
95.34 percentage of gluten degradation
Interval -899.5 to 99.6
|
64.40 percentage of gluten degradation
Interval -91.2 to 96.6
|
85.69 percentage of gluten degradation
Interval -39.5 to 98.7
|
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SECONDARY outcome
Timeframe: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dosePopulation: Pharmacokinetic (PK) population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Parts 1 and 2 PvP001 and PvP002; however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dosePopulation: PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Parts 1 and 2 PvP001 and PvP002; however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dosePopulation: PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Parts 1 and 2 PvP001 and PvP002; however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dosePopulation: PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Parts 1 and 2 PvP001 and PvP002; however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dosePopulation: PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Parts 1 and 2 PvP001 and PvP002; however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Day 14 and Day 28Population: Safety population included all participants who received at least one dose of study drug. As planned, data was collected and analyzed at Day 14 and Day 28 after the final Cohort Treatment Day to test for ADA to PvP001 and PvP002; therefore, sequence-wise data is reported for Parts 1 and 2.
Outcome measures
| Measure |
Part 3, Group 4: PvP003 600 mg (3H)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
|
Part 3, Group 5: PvP003 150 mg (3J)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
|
Part 3, Group 1: PvP003 600 mg (3B)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
|
Part 3, Group 2: PvP003 600 mg (3D)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
|
Part 3, Group 3: PvP003 600 mg (3F)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
|
Part 1, (1C-2): PvP001 300 mg
n=3 Participants
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1D-2): PvP001 900 mg
n=3 Participants
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1E-2): PvP002 600 mg
n=3 Participants
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 2, Group 1: PvP001 900 mg (2B)
n=3 Participants
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C)
n=1 Participants
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
|
Part 2, Group 2: PvP002 Placebo (2D)
n=3 Participants
PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
|
Part 2, Group 2: PvP002 600 mg (2E)
n=3 Participants
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
|
Part 2, Group 3: PvP001 300 mg (2G)
n=2 Participants
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
|
Part 2, Group 3: PvP001 600 mg (2H)
n=2 Participants
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
|
Part 2, Group 3: PvP001 900 mg (2J)
n=2 Participants
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
n=2 Participants
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
n=4 Participants
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
n=5 Participants
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
n=4 Participants
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
n=4 Participants
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
n=4 Participants
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
n=4 Participants
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
n=4 Participants
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
n=4 Participants
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
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Part 1 and Part 2: Number of Participants With Anti-drug Antibodies (ADA) for PvP001 and PvP002
Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Anti-drug Antibodies (ADA) for PvP001 and PvP002
Day 28
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cohort Treatment Day up to Day 7Population: Safety population included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed only for Part 1 (1B-1 and 1B-2, 1C-1 and 1C-2, 1D-1 and 1D-2) in healthy or CeD participants of the study. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure.
MTD was defined as the maximum dose that was determined to be safe and tolerable for Part 1 (1B-1 and 1B-2, 1C-1 and 1C-2, 1D-1 and 1D-2) in healthy or CeD participants.
Outcome measures
| Measure |
Part 3, Group 4: PvP003 600 mg (3H)
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
|
Part 3, Group 5: PvP003 150 mg (3J)
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
|
Part 3, Group 1: PvP003 600 mg (3B)
n=22 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
|
Part 3, Group 2: PvP003 600 mg (3D)
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
|
Part 3, Group 3: PvP003 600 mg (3F)
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
|
Part 1, (1C-2): PvP001 300 mg
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1D-2): PvP001 900 mg
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1E-2): PvP002 600 mg
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 2, Group 1: PvP001 900 mg (2B)
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
|
Part 2, Group 2: PvP002 Placebo (2D)
PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
|
Part 2, Group 2: PvP002 600 mg (2E)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
|
Part 2, Group 3: PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
|
Part 2, Group 3: PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
|
Part 2, Group 3: PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
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Part 1: Maximum Tolerated Dose (MTD) of PvP001
|
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900 mg
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22)Population: Safety population included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed only in the Part 2 of this study.
Outcome measures
| Measure |
Part 3, Group 4: PvP003 600 mg (3H)
n=9 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
|
Part 3, Group 5: PvP003 150 mg (3J)
n=9 Participants
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
|
Part 3, Group 1: PvP003 600 mg (3B)
n=13 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
|
Part 3, Group 2: PvP003 600 mg (3D)
n=12 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
|
Part 3, Group 3: PvP003 600 mg (3F)
n=13 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
|
Part 1, (1C-2): PvP001 300 mg
n=24 Participants
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1D-2): PvP001 900 mg
n=8 Participants
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1E-2): PvP002 600 mg
n=8 Participants
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 2, Group 1: PvP001 900 mg (2B)
n=8 Participants
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
|
Part 2, Group 2: PvP002 Placebo (2D)
PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
|
Part 2, Group 2: PvP002 600 mg (2E)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
|
Part 2, Group 3: PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
|
Part 2, Group 3: PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
|
Part 2, Group 3: PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants Reporting One or More TEAEs and TESAEs for PvP001 and PvP002
TEAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants Reporting One or More TEAEs and TESAEs for PvP001 and PvP002
TESAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort Treatment Day up to 5 days after final Cohort Treatment Day (up to Day 10)Population: Safety population included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed for Part 3 of this study.
Outcome measures
| Measure |
Part 3, Group 4: PvP003 600 mg (3H)
n=6 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
|
Part 3, Group 5: PvP003 150 mg (3J)
n=6 Participants
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
|
Part 3, Group 1: PvP003 600 mg (3B)
n=36 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
|
Part 3, Group 2: PvP003 600 mg (3D)
n=6 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
|
Part 3, Group 3: PvP003 600 mg (3F)
n=6 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
|
Part 1, (1C-2): PvP001 300 mg
n=13 Participants
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1D-2): PvP001 900 mg
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1E-2): PvP002 600 mg
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 2, Group 1: PvP001 900 mg (2B)
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
|
Part 2, Group 2: PvP002 Placebo (2D)
PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
|
Part 2, Group 2: PvP002 600 mg (2E)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
|
Part 2, Group 3: PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
|
Part 2, Group 3: PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
|
Part 2, Group 3: PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 3: Number of Participants Reporting One or More TEAEs and TESAEs With PvP003 After a Single Dose
TEAEs
|
0 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants Reporting One or More TEAEs and TESAEs With PvP003 After a Single Dose
TESAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dosePopulation: PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Part 3, PvP003 150 mg and 600 mg cohorts; however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post dosePopulation: PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Part 3, PvP003 150 mg and 600 mg cohorts; however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post dosePopulation: PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Part 3, PvP003 150 mg and 600 mg cohorts; however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post dosePopulation: PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Part 3, PvP003 150 mg and 600 mg cohorts; however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post dosePopulation: PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Part 3, PvP003 150 mg and 600 mg cohorts; however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Day 14 and Day 28Population: Safety population included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed only for Part 3 of this study. As planned, data was collected and analyzed at Day 14 and Day 28 after the final Cohort Treatment Day to test for ADA to PvP003; therefore, sequence-wise data is reported for Part 3.
Outcome measures
| Measure |
Part 3, Group 4: PvP003 600 mg (3H)
n=5 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
|
Part 3, Group 5: PvP003 150 mg (3J)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
|
Part 3, Group 1: PvP003 600 mg (3B)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
|
Part 3, Group 2: PvP003 600 mg (3D)
n=4 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
|
Part 3, Group 3: PvP003 600 mg (3F)
n=1 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
|
Part 1, (1C-2): PvP001 300 mg
n=3 Participants
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1D-2): PvP001 900 mg
n=3 Participants
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1E-2): PvP002 600 mg
n=3 Participants
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 2, Group 1: PvP001 900 mg (2B)
n=5 Participants
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C)
n=8 Participants
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
|
Part 2, Group 2: PvP002 Placebo (2D)
PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
|
Part 2, Group 2: PvP002 600 mg (2E)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
|
Part 2, Group 3: PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
|
Part 2, Group 3: PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
|
Part 2, Group 3: PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 3: Number of Participants With ADA for PvP003 150 mg and 600 mg Single Dose
Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Part 3: Number of Participants With ADA for PvP003 150 mg and 600 mg Single Dose
Day 28
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dosePopulation: PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Part 4, PvP003 600 mg, TID (4B); however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time-points for all arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dosePopulation: PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Part 4, PvP003 600 mg, TID (4B); however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time points for all arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dosePopulation: PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Part 4, PvP003 600 mg, TID (4B); however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time points for all arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dosePopulation: PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Part 4, PvP003 600 mg, TID (4B); however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time points for all arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dosePopulation: PK population included all participants who received at least one dose of study drug and had any PK data. As planned, this outcome measure was to be assessed for Part 4, PvP003 600 mg, TID (4B); however, PK analysis was not conducted since plasma concentrations were below the LLOQ at all sampling time points for all arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Day 14 and Day 28Population: Safety population included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed only for Part 4 of this study. As planned, data was collected and analyzed at Day 14 and Day 28 after Day 5 of the second Cohort Treatment Period to test for ADA to PvP003; therefore, sequence-wise data is reported for Part 4.
Outcome measures
| Measure |
Part 3, Group 4: PvP003 600 mg (3H)
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
|
Part 3, Group 5: PvP003 150 mg (3J)
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
|
Part 3, Group 1: PvP003 600 mg (3B)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
|
Part 3, Group 2: PvP003 600 mg (3D)
n=3 Participants
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
|
Part 3, Group 3: PvP003 600 mg (3F)
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
|
Part 1, (1C-2): PvP001 300 mg
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1D-2): PvP001 900 mg
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1E-2): PvP002 600 mg
PvP001 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 2, Group 1: PvP001 900 mg (2B)
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
|
Part 2, Group 2: PvP002 Placebo (2D)
PvP002 comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
|
Part 2, Group 2: PvP002 600 mg (2E)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
|
Part 2, Group 3: PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
|
Part 2, Group 3: PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
|
Part 2, Group 3: PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C) + PvP001 900 mg (2B) + PvP001 Placebo (2A)
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C, followed by PvP001 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B, further followed by PvP001 placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 Comparator (2D) + PvP002 600 mg (2E)
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D, followed by PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 2: PvP002 600 mg (2E) + PvP002 Comparator (2D)
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E, followed by PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 300 mg (2G)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 300 mg (2G) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2F) + PvP001 600 mg (2H)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F, followed by PvP001 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 600 mg (2H) + PvP001 Placebo (2F)
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H, followed by PvP001 placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 Placebo (2I) + PvP001 900 mg (2J)
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I, followed by PvP001 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
Part 2, Group 3: PvP001 900 mg (2J) + PvP001 Placebo (2I)
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J, followed by PvP001 placebo-matching liquid (2I), orally, single dose on Cohort Treatment Day of Cohort 2I in healthy participants. There was a washout period of 7 days between each Cohort Treatment Day.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 4: Number of Participants With ADA for PvP003 600 mg Multiple Dose
Day 14
|
—
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 4: Number of Participants With ADA for PvP003 600 mg Multiple Dose
Day 28
|
—
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1, (1A-1): PvP001 Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1, (1B-1): PvP001 100 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1, (1C-1): PvP001 300 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1, (1D-1): PvP001 900 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1, (1E-1): PvP002 600 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1, (1A-2): PvP001 Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1, (1B-2): PvP001 100 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1, (1C-2): PvP001 300 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1, (1D-2): PvP001 900 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1, (1E-2): PvP002 600 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2, Group 1: PvP001 Placebo (2A)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2, Group 1: PvP001 900 mg (2B)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2, Group 1: PvP001 900 mg With PPI (2C)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2, Group 2: PvP002 Comparator (2D)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2, Group 2: PvP002 600 mg (2E)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2, Group 3: PvP001 Placebo (2F and 2I)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2, Group 3: PvP001 300 mg (2G)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2, Group 3: PvP001 600 mg (2H)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2, Group 3: PvP001 900 mg (2J)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 3, Group 1: PvP003 Placebo (3A, 3C, 3E, 3G and 3I)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 3, Group 1: PvP003 600 mg (3B)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 3, Group 2: PvP003 600 mg (3D)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 3, Group 3: PvP003 600 mg (3F)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 3, Group 4: PvP003 600 mg (3H)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 3, Group 5: PvP003 150 mg (3J)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 4: PvP003 Placebo, TID (4A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 4: PvP003 600 mg, TID (4B)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1, (1A-1): PvP001 Placebo
n=3 participants at risk
PvP001 (TAK-062 liquid formulation) placebo-matching liquid, orally, single dose on Cohort Treatment Day in healthy participants.
|
Part 1, (1B-1): PvP001 100 mg
n=3 participants at risk
PvP001 (TAK-062 liquid formulation) 100 milligram (mg), orally, single dose on Cohort Treatment Day in healthy participants.
|
Part 1, (1C-1): PvP001 300 mg
n=3 participants at risk
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in healthy participants.
|
Part 1, (1D-1): PvP001 900 mg
n=3 participants at risk
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in healthy participants.
|
Part 1, (1E-1): PvP002 600 mg
n=3 participants at risk
PvP002 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in healthy participants.
|
Part 1, (1A-2): PvP001 Placebo
n=3 participants at risk
PvP001 (TAK-062 liquid formulation) placebo-matching liquid, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1B-2): PvP001 100 mg
n=3 participants at risk
PvP001 (TAK-062 liquid formulation) 100 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1C-2): PvP001 300 mg
n=3 participants at risk
PvP001 (TAK-062 liquid formulation) 300 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1D-2): PvP001 900 mg
n=3 participants at risk
PvP001 (TAK-062 liquid formulation) 900 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 1, (1E-2): PvP002 600 mg
n=1 participants at risk
PvP002 (TAK-062 capsule formulation) 600 mg, orally, single dose on Cohort Treatment Day in CeD participants.
|
Part 2, Group 1: PvP001 Placebo (2A)
n=13 participants at risk
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2A), orally, single dose on Cohort Treatment Day of Cohort 2A in healthy participants.
|
Part 2, Group 1: PvP001 900 mg (2B)
n=12 participants at risk
PvP001 (TAK-062 liquid formulation) 900 mg (2B), orally, single dose on Cohort Treatment Day of Cohort 2B in healthy participants.
|
Part 2, Group 1: PvP001 900 mg With PPI (2C)
n=13 participants at risk
PvP001 (TAK-062 liquid formulation) 900 mg following 7 days of PPI treatment (2C), orally, single dose on Cohort Treatment Day of Cohort 2C in healthy participants.
|
Part 2, Group 2: PvP002 Comparator (2D)
n=9 participants at risk
PvP002 capsule comparator (sterile water) (2D), orally, single dose on Cohort Treatment Day of Cohort 2D in healthy participants.
|
Part 2, Group 2: PvP002 600 mg (2E)
n=9 participants at risk
PvP002 (TAK-062 capsule formulation) 600 mg (2E), orally, single dose on Cohort Treatment Day of Cohort 2E in healthy participants.
|
Part 2, Group 3: PvP001 Placebo (2F and 2I)
n=24 participants at risk
PvP001 (TAK-062 liquid formulation) placebo-matching liquid (2F), orally, single dose on Cohort Treatment Day of Cohort 2F and 2I in healthy participants.
|
Part 2, Group 3: PvP001 300 mg (2G)
n=8 participants at risk
PvP001 (TAK-062 liquid formulation) 300 mg (2G), orally, single dose on Cohort Treatment Day of Cohort 2G in healthy participants.
|
Part 2, Group 3: PvP001 600 mg (2H)
n=8 participants at risk
PvP001 (TAK-062 liquid formulation) 600 mg (2H), orally, single dose on Cohort Treatment Day of Cohort 2H in healthy participants.
|
Part 2, Group 3: PvP001 900 mg (2J)
n=8 participants at risk
PvP001 (TAK-062 liquid formulation) 900 mg (2J), orally, single dose on Cohort Treatment Day of Cohort 2J in healthy participants.
|
Part 3, Group 1: PvP003 Placebo (3A, 3C, 3E, 3G and 3I)
n=36 participants at risk；n=35 participants at risk
PvP003 (TAK-062 tablet formulation) placebo-matching tablet orally, single dose on Cohorts Treatment Day 1 of 3A, 3C, 3E, 3G or 3I in healthy participants. For Cohort 3A: with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal. For Cohorts 3C and 3I: without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal. For Cohort 3E: without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003; and for Cohort 3G: without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal.
|
Part 3, Group 1: PvP003 600 mg (3B)
n=6 participants at risk
PvP003 (TAK-062 tablet formulation) 600 mg (3B) with pretreatment buffer solution administered prior to the PvP003 before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3B in healthy participants.
|
Part 3, Group 2: PvP003 600 mg (3D)
n=6 participants at risk
PvP003 (TAK-062 tablet formulation) 600 mg (3D) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3D in healthy participants.
|
Part 3, Group 3: PvP003 600 mg (3F)
n=6 participants at risk
PvP003 (TAK-062 tablet formulation) 600 mg (3F) without pretreatment buffer solution administered after an approximately 50 mL portion of standardized 1 gram gluten-containing study meal and then remaining portion of the 1 gram gluten-containing study meal was ingested after administration of PvP0003, orally, single dose on Cohort Treatment Day of Cohort 3F in healthy participants.
|
Part 3, Group 4: PvP003 600 mg (3H)
n=6 participants at risk
PvP003 (TAK-062 tablet formulation) 600 mg (3H) without pretreatment buffer solution before standardized gluten-free study meal followed by a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3H in healthy participants.
|
Part 3, Group 5: PvP003 150 mg (3J)
n=13 participants at risk
PvP003 (TAK-062 tablet formulation) 150 mg (3J) without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal, orally, single dose on Cohort Treatment Day of Cohort 3J in healthy participants.
|
Part 4: PvP003 Placebo, TID (4A)
n=6 participants at risk
PvP003 (TAK-062 tablet formulation) placebo-matching tablet, administered as two tablets of PvP003 placebo, orally, TID on Treatment Days 1 to 5 (4A) of Cohort Treatment Period 1 or 2 in healthy participants.
|
Part 4: PvP003 600 mg, TID (4B)
n=6 participants at risk
PvP003 (TAK-062 tablet formulation) 600 mg, administered as two tablets of PvP003 300 mg, orally, TID on Treatment Days 1 to 5 (4B) of Cohort Treatment Period 1 or 2 in healthy participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
2/36 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.8%
1/36 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.8%
1/36 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
66.7%
2/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.2%
1/24 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
2/36 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
2/36 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.8%
1/36 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug in Part 1, 2, 3 and 4: Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) in Part 1; Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22 in Part 2, and up to Day 10 in Part 3); and Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up Day 28) in Part 4
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER