Trial Outcomes & Findings for Phase 1 TAK-925 Study in Healthy Adult and Elderly Volunteers and Participants With Narcolepsy (NCT NCT03332784)
NCT ID: NCT03332784
Last Updated: 2021-03-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
58 participants
Primary outcome timeframe
Baseline up to Day 7
Results posted on
2021-03-30
Participant Flow
Participants took part in the study at 3 investigative sites in Japan from 04 November 2017 to 04 September 2018.
Healthy adult and elderly participants were enrolled to receive TAK-925 or placebo in Cohorts 1 and 2 under alternating panel design and in Cohorts S1, S2, 3, and 4 under parallel design of Part 1, and participants with type 1 narcolepsy were enrolled to receive TAK-925 or placebo in a 2-period cross-over design in Cohorts 5, 6, and 7 of Part 2.
Participant milestones
| Measure |
Part 1 Cohort 1: TAK-925 7 mg + TAK-925 28 mg + TAK-925 112 mg
TAK-925 7 milligram (mg), infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 28 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 112 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group A in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 7 mg + TAK-925 28 mg + Placebo
TAK-925 7 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 28 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group B in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 7 mg + Placebo + TAK-925 112 mg
TAK-925 7 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 112 mg, infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group C in double-blind, alternating panel.
|
Part 1 Cohort 1: Placebo + TAK-925 28 mg + TAK-925 112 mg
TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 28 mg, infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 112 mg, infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group D in double-blind, alternating panel.
|
Part 1 Cohort 2:TAK-925 14 mg +TAK-925 56 mg +TAK-925 134.4 mg
TAK-925 14 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 56 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 134.4 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group E in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 14 mg + TAK-925 56 mg + Placebo
TAK-925 14 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 56 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 3 in Group F in healthy adults in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 14 mg + Placebo + TAK-925 134.4 mg
TAK-925 14 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 134.4 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group G in double-blind, alternating panel.
|
Part 1 Cohort 2: Placebo + TAK-925 56 mg + TAK-925 134.4 mg
TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 56 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 134.4 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5: TAK-925 44.8 mg + Placebo
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group I under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
|
Part 2 Cohort 5: Placebo + TAK-925 44.8 mg
TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 44.8 mg, infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group J under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
|
Part 2 Cohort 6: TAK-925 11.2 mg + Placebo
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group K under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
|
Part 2 Cohort 6: Placebo + TAK-925 11.2 mg
TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 11.2 mg, infusion, intravenously, once on Day 1 Period 2 (Day 3) in participants with type 1 narcolepsy in Group L under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
|
Part 2 Cohort 7: TAK-925 5 mg + Placebo
TAK-925 5 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group M under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
|
Part 2 Cohort 7: Placebo + TAK-925 5 mg
TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 5 mg, infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group N under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications
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Parts 1 and 2 - Period 1 (1 Day)
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Parts 1 and 2 - Period 1 (1 Day)
COMPLETED
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Parts 1 and 2 - Period 1 (1 Day)
NOT COMPLETED
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Parts 1 and 2- Period 2 (1 Day)
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Parts 1 and 2- Period 2 (1 Day)
COMPLETED
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Parts 1 and 2- Period 2 (1 Day)
NOT COMPLETED
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Part 1- Period 3 (1 Day)
STARTED
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Part 1- Period 3 (1 Day)
COMPLETED
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Part 1- Period 3 (1 Day)
NOT COMPLETED
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Reasons for withdrawal
| Measure |
Part 1 Cohort 1: TAK-925 7 mg + TAK-925 28 mg + TAK-925 112 mg
TAK-925 7 milligram (mg), infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 28 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 112 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group A in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 7 mg + TAK-925 28 mg + Placebo
TAK-925 7 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 28 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group B in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 7 mg + Placebo + TAK-925 112 mg
TAK-925 7 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 112 mg, infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group C in double-blind, alternating panel.
|
Part 1 Cohort 1: Placebo + TAK-925 28 mg + TAK-925 112 mg
TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 28 mg, infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 112 mg, infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group D in double-blind, alternating panel.
|
Part 1 Cohort 2:TAK-925 14 mg +TAK-925 56 mg +TAK-925 134.4 mg
TAK-925 14 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 56 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 134.4 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group E in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 14 mg + TAK-925 56 mg + Placebo
TAK-925 14 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 56 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 3 in Group F in healthy adults in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 14 mg + Placebo + TAK-925 134.4 mg
TAK-925 14 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 134.4 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group G in double-blind, alternating panel.
|
Part 1 Cohort 2: Placebo + TAK-925 56 mg + TAK-925 134.4 mg
TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 56 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 134.4 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5: TAK-925 44.8 mg + Placebo
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group I under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
|
Part 2 Cohort 5: Placebo + TAK-925 44.8 mg
TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 44.8 mg, infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group J under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
|
Part 2 Cohort 6: TAK-925 11.2 mg + Placebo
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group K under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
|
Part 2 Cohort 6: Placebo + TAK-925 11.2 mg
TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 11.2 mg, infusion, intravenously, once on Day 1 Period 2 (Day 3) in participants with type 1 narcolepsy in Group L under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
|
Part 2 Cohort 7: TAK-925 5 mg + Placebo
TAK-925 5 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group M under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
|
Part 2 Cohort 7: Placebo + TAK-925 5 mg
TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 5 mg, infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group N under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications
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Parts 1 and 2 - Period 1 (1 Day)
Adverse Event
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0
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1
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0
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Part 1 Cohort 1: TAK-925 7 mg + TAK-925 28 mg + TAK-925 112 mg
n=2 Participants
TAK-925 7 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 28 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 112 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group A in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 7 mg + TAK-925 28 mg + Placebo
n=2 Participants
TAK-925 7 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 28 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group B in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 7 mg + Placebo + TAK-925 112 mg
n=2 Participants
TAK-925 7 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 112 mg, infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group C in double-blind, alternating panel.
|
Part 1 Cohort 1: Placebo + TAK-925 28 mg + TAK-925 112 mg
n=2 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 28 mg, infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 112 mg, infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group D in double-blind, alternating panel.
|
Part 1 Cohort 2:TAK-925 14 mg +TAK-925 56 mg +TAK-925 134.4 mg
n=2 Participants
TAK-925 14 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 56 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 134.4 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group E in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 14 mg + TAK-925 56 mg + Placebo
n=2 Participants
TAK-925 14 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 56 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 3 in Group F in healthy adults in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 14 mg + Placebo + TAK-925 134.4 mg
n=2 Participants
TAK-925 14 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 134.4 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group G in double-blind, alternating panel.
|
Part 1 Cohort 2: Placebo + TAK-925 56 mg + TAK-925 134.4 mg
n=2 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 56 mg infusion, intravenously, once on Day 1 of Period 2, further followed by TAK-925 134.4 mg infusion, intravenously, once on Day 1 of Period 3 in healthy adults in Group H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
n=4 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1: Cohort S1 TAK-925 180 mg
n=6 Participants
TAK-925 180 mg, infusion, intravenously, once, over 9 hours on Day 1 in healthy adults in double-blind, parallel group.
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Part 1: Cohort S2 TAK-925 240 mg
n=6 Participants
TAK-925 240 mg, infusion, intravenously, once, over 9 hours on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1: Cohort 3 Placebo
n=2 Participants
TAK-925 placebo-matching infusion, intravenously, once, over 9 hours on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1: Cohort 3 TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once, over 9 hours on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1: Cohort 4 TAK-925 112 mg
n=4 Participants
TAK-925 112 mg, infusion, intravenously, once, over 9 hours on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5: TAK-925 44.8 mg + Placebo
n=2 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group I under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
|
Part 2 Cohort 5, Part J: TAK-925 Placebo + 44.8 mg
n=2 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 44.8 mg, infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group J under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
|
Part 2 Cohort 6: TAK-925 11.2 mg + Placebo
n=2 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group K under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
|
Part 2 Cohort 6: Placebo + TAK-925 11.2 mg
n=2 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 11.2 mg, infusion, intravenously, once on Day 1 Period 2 (Day 3) in participants with type 1 narcolepsy in Group L under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
|
Part 2 Cohort 7: TAK-925 5 mg + Placebo
n=3 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group M under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications.
|
Part 2 Cohort 7: Placebo + TAK-925 5 mg
n=3 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 of Period 1, followed by TAK-925 5 mg, infusion, intravenously, once on Day 1 of Period 2 (Day 3) in participants with type 1 narcolepsy in Group N under 2-period crossover design. A washout period of 7 days was required before the dosing on Day 1 for prior medications
|
Total
n=58 Participants
Total of all reporting groups
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Age, Continuous
|
29.0 years
STANDARD_DEVIATION 5.66 • n=2 Participants
|
25.5 years
STANDARD_DEVIATION 4.95 • n=2 Participants
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22.0 years
STANDARD_DEVIATION 2.83 • n=2 Participants
|
30.0 years
STANDARD_DEVIATION 4.24 • n=2 Participants
|
24.5 years
STANDARD_DEVIATION 3.54 • n=2 Participants
|
28.0 years
STANDARD_DEVIATION 9.90 • n=2 Participants
|
28.5 years
STANDARD_DEVIATION 9.19 • n=2 Participants
|
34.5 years
STANDARD_DEVIATION 4.95 • n=2 Participants
|
24.8 years
STANDARD_DEVIATION 4.57 • n=4 Participants
|
24.5 years
STANDARD_DEVIATION 5.75 • n=6 Participants
|
27.5 years
STANDARD_DEVIATION 6.72 • n=6 Participants
|
72.5 years
STANDARD_DEVIATION 3.54 • n=2 Participants
|
67.7 years
STANDARD_DEVIATION 2.94 • n=6 Participants
|
21.3 years
STANDARD_DEVIATION 0.50 • n=4 Participants
|
21.5 years
STANDARD_DEVIATION 4.95 • n=2 Participants
|
33.0 years
STANDARD_DEVIATION 15.56 • n=2 Participants
|
25.5 years
STANDARD_DEVIATION 7.78 • n=2 Participants
|
38.5 years
STANDARD_DEVIATION 0.71 • n=2 Participants
|
42.3 years
STANDARD_DEVIATION 20.11 • n=3 Participants
|
33.7 years
STANDARD_DEVIATION 4.51 • n=3 Participants
|
33.7 years
STANDARD_DEVIATION 16.26 • n=58 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
12 Participants
n=58 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
46 Participants
n=58 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Japan
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
2 Participants
n=2 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
58 Participants
n=58 Participants
|
|
Body Mass Index (BMI)
|
22.25 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 2.475 • n=2 Participants
|
22.35 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 0.919 • n=2 Participants
|
20.85 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 2.899 • n=2 Participants
|
22.10 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 0.141 • n=2 Participants
|
21.55 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 2.616 • n=2 Participants
|
20.90 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 0.424 • n=2 Participants
|
23.40 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 2.687 • n=2 Participants
|
22.15 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 1.626 • n=2 Participants
|
22.65 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 1.912 • n=4 Participants
|
20.48 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 0.768 • n=6 Participants
|
21.05 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 1.325 • n=6 Participants
|
23.00 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 2.263 • n=2 Participants
|
23.22 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 3.451 • n=6 Participants
|
22.03 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 2.791 • n=4 Participants
|
32.30 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 10.041 • n=2 Participants
|
24.60 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 2.546 • n=2 Participants
|
23.60 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 0.707 • n=2 Participants
|
26.45 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 8.697 • n=2 Participants
|
26.10 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 7.146 • n=3 Participants
|
29.57 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 5.689 • n=3 Participants
|
23.19 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 4.072 • n=58 Participants
|
|
Height
|
176.0 centimeter (cm)
STANDARD_DEVIATION 1.41 • n=2 Participants
|
167.0 centimeter (cm)
STANDARD_DEVIATION 2.83 • n=2 Participants
|
174.5 centimeter (cm)
STANDARD_DEVIATION 2.12 • n=2 Participants
|
177.0 centimeter (cm)
STANDARD_DEVIATION 8.49 • n=2 Participants
|
170.0 centimeter (cm)
STANDARD_DEVIATION 4.24 • n=2 Participants
|
173.0 centimeter (cm)
STANDARD_DEVIATION 1.41 • n=2 Participants
|
170.0 centimeter (cm)
STANDARD_DEVIATION 9.90 • n=2 Participants
|
171.5 centimeter (cm)
STANDARD_DEVIATION 6.36 • n=2 Participants
|
173.5 centimeter (cm)
STANDARD_DEVIATION 5.80 • n=4 Participants
|
173.0 centimeter (cm)
STANDARD_DEVIATION 3.16 • n=6 Participants
|
168.8 centimeter (cm)
STANDARD_DEVIATION 5.00 • n=6 Participants
|
149.0 centimeter (cm)
STANDARD_DEVIATION 0.00 • n=2 Participants
|
159.5 centimeter (cm)
STANDARD_DEVIATION 4.64 • n=6 Participants
|
171.0 centimeter (cm)
STANDARD_DEVIATION 5.89 • n=4 Participants
|
155.5 centimeter (cm)
STANDARD_DEVIATION 0.71 • n=2 Participants
|
174.5 centimeter (cm)
STANDARD_DEVIATION 6.36 • n=2 Participants
|
171.0 centimeter (cm)
STANDARD_DEVIATION 1.41 • n=2 Participants
|
159.5 centimeter (cm)
STANDARD_DEVIATION 2.12 • n=2 Participants
|
160.7 centimeter (cm)
STANDARD_DEVIATION 4.73 • n=3 Participants
|
168.3 centimeter (cm)
STANDARD_DEVIATION 11.55 • n=3 Participants
|
168.1 centimeter (cm)
STANDARD_DEVIATION 8.11 • n=58 Participants
|
|
Weight
|
68.15 kilogram (kg)
STANDARD_DEVIATION 7.707 • n=2 Participants
|
62.65 kilogram (kg)
STANDARD_DEVIATION 0.636 • n=2 Participants
|
62.90 kilogram (kg)
STANDARD_DEVIATION 10.607 • n=2 Participants
|
69.60 kilogram (kg)
STANDARD_DEVIATION 6.930 • n=2 Participants
|
60.95 kilogram (kg)
STANDARD_DEVIATION 5.445 • n=2 Participants
|
62.45 kilogram (kg)
STANDARD_DEVIATION 1.909 • n=2 Participants
|
68.80 kilogram (kg)
STANDARD_DEVIATION 14.849 • n=2 Participants
|
63.85 kilogram (kg)
STANDARD_DEVIATION 8.839 • n=2 Participants
|
68.73 kilogram (kg)
STANDARD_DEVIATION 1.941 • n=4 Participants
|
61.12 kilogram (kg)
STANDARD_DEVIATION 2.860 • n=6 Participants
|
59.55 kilogram (kg)
STANDARD_DEVIATION 6.142 • n=6 Participants
|
51.30 kilogram (kg)
STANDARD_DEVIATION 4.101 • n=2 Participants
|
58.77 kilogram (kg)
STANDARD_DEVIATION 10.388 • n=6 Participants
|
63.88 kilogram (kg)
STANDARD_DEVIATION 7.029 • n=4 Participants
|
78.45 kilogram (kg)
STANDARD_DEVIATION 24.112 • n=2 Participants
|
74.95 kilogram (kg)
STANDARD_DEVIATION 0.071 • n=2 Participants
|
69.05 kilogram (kg)
STANDARD_DEVIATION 1.202 • n=2 Participants
|
67.70 kilogram (kg)
STANDARD_DEVIATION 23.900 • n=2 Participants
|
67.57 kilogram (kg)
STANDARD_DEVIATION 22.212 • n=3 Participants
|
83.43 kilogram (kg)
STANDARD_DEVIATION 15.970 • n=3 Participants
|
65.20 kilogram (kg)
STANDARD_DEVIATION 10.994 • n=58 Participants
|
|
Smoking Classification
Non-smoker
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=2 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
44 Participants
n=58 Participants
|
|
Smoking Classification
Current smoker
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=58 Participants
|
|
Smoking Classification
Former smoker
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
11 Participants
n=58 Participants
|
|
Alcohol Classification
Daily
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=58 Participants
|
|
Alcohol Classification
A Few Times Per Week
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
10 Participants
n=58 Participants
|
|
Alcohol Classification
A Few Times Per Month
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
25 Participants
n=58 Participants
|
|
Alcohol Classification
Non-alcoholic
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
22 Participants
n=58 Participants
|
|
Caffeine Classification
Had caffeine consumption
|
2 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
5 Participants
n=6 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
35 Participants
n=58 Participants
|
|
Caffeine Classification
Had no caffeine consumption
|
0 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
23 Participants
n=58 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 7Population: The safety analysis set was defined as all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=11 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=6 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=6 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=5 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
n=6 Participants
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
n=6 Participants
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
n=4 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
n=6 Participants
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
n=6 Participants
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
n=2 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
n=4 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
n=13 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=4 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=4 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=6 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 7Population: The safety analysis set was defined as all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=11 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=6 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=6 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=5 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
n=6 Participants
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
n=6 Participants
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
n=4 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
n=6 Participants
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
n=6 Participants
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
n=2 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
n=4 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
n=13 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=4 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=4 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=6 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experience at Least One TEAE Related to Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 7Population: The safety analysis set was defined as all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=11 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=6 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=6 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=5 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
n=6 Participants
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
n=6 Participants
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
n=4 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
n=6 Participants
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
n=6 Participants
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
n=2 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
n=4 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
n=13 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=4 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=4 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=6 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experience at Least One TEAE Related to Body Weight
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 7Population: The safety analysis set was defined as all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=11 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=6 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=6 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=5 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
n=6 Participants
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
n=6 Participants
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
n=4 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
n=6 Participants
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
n=6 Participants
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
n=2 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
n=4 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
n=13 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=4 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=4 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=6 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experience at Least One TEAE Related to 12-lead Electrocardiogram (ECG)
|
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
|
PRIMARY outcome
Timeframe: Baseline up to Day 7Population: The safety analysis set was defined as all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=11 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=6 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=6 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=5 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
n=6 Participants
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
n=6 Participants
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
n=4 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
n=6 Participants
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
n=6 Participants
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
n=2 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
n=4 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
n=13 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=4 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=4 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=6 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experience at Least One TEAE Related to Clinical Laboratory Tests
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or cerebrospinal fluid (CSF) concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=6 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=6 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=5 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=6 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
n=6 Participants
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
n=6 Participants
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
n=6 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
n=6 Participants
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
n=4 Participants
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-925 and Its Metabolites M1 and M2
TAK-925
|
138.0 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 22.546
|
323.1 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 45.793
|
513.3 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 81.392
|
1055 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 178.49
|
2069 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 298.89
|
2655 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 495.32
|
2994 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 164.73
|
4542 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 698.25
|
2546 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 274.48
|
2011 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 195.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-925 and Its Metabolites M1 and M2
Metabolite M1
|
74.10 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 31.837
|
170.7 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 50.607
|
293.1 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 120.91
|
613.8 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 218.79
|
1272 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 409.93
|
1724 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 596.04
|
1762 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 204.30
|
3094 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 740.81
|
1037 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 343.80
|
996.3 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 321.79
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-925 and Its Metabolites M1 and M2
Metabolite M2
|
0.3676 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 0.89268
|
1.940 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 2.5750
|
5.893 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 2.8201
|
9.225 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 6.3231
|
22.79 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 19.464
|
31.23 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 25.058
|
28.69 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 4.9460
|
56.79 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 21.993
|
15.96 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 9.4609
|
16.81 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 8.7980
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=4 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=4 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=6 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-925 and Its Metabolites M1 and M2
TAK-925
|
910.8 h*ng/mL
Standard Deviation 275.10
|
198.7 h*ng/mL
Standard Deviation 13.540
|
86.15 h*ng/mL
Standard Deviation 14.777
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-925 and Its Metabolites M1 and M2
Metabolite M1
|
623.6 h*ng/mL
Standard Deviation 516.16
|
100.7 h*ng/mL
Standard Deviation 55.904
|
52.25 h*ng/mL
Standard Deviation 17.041
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-925 and Its Metabolites M1 and M2
Metabolite M2
|
10.90 h*ng/mL
Standard Deviation 22.384
|
3.435 h*ng/mL
Standard Deviation 2.0430
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=6 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=6 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=5 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=6 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
n=6 Participants
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
n=6 Participants
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
n=6 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
n=6 Participants
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
n=4 Participants
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 and Its Metabolites M1 and M2
TAK-925
|
141.8 h*ng/mL
Standard Deviation 22.744
|
328.1 h*ng/mL
Standard Deviation 51.138
|
523.5 h*ng/mL
Standard Deviation 88.288
|
1065 h*ng/mL
Standard Deviation 187.70
|
2092 h*ng/mL
Standard Deviation 319.85
|
2682 h*ng/mL
Standard Deviation 519.45
|
3013 h*ng/mL
Standard Deviation 160.21
|
4585 h*ng/mL
Standard Deviation 689.28
|
2590 h*ng/mL
Standard Deviation 283.03
|
2028 h*ng/mL
Standard Deviation 196.21
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 and Its Metabolites M1 and M2
Metabolite M1
|
75.77 h*ng/mL
Standard Deviation 32.409
|
173.5 h*ng/mL
Standard Deviation 53.475
|
296.1 h*ng/mL
Standard Deviation 122.50
|
618.9 h*ng/mL
Standard Deviation 221.98
|
1284 h*ng/mL
Standard Deviation 409.94
|
1737 h*ng/mL
Standard Deviation 606.78
|
1764 h*ng/mL
Standard Deviation 202.65
|
3112 h*ng/mL
Standard Deviation 745.48
|
1052 h*ng/mL
Standard Deviation 350.05
|
1001 h*ng/mL
Standard Deviation 323.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 and Its Metabolites M1 and M2
Metabolite M2
|
2.900 h*ng/mL
|
5.302 h*ng/mL
Standard Deviation 1.6898
|
6.416 h*ng/mL
Standard Deviation 1.0512
|
9.796 h*ng/mL
Standard Deviation 6.6369
|
23.79 h*ng/mL
Standard Deviation 19.535
|
32.29 h*ng/mL
Standard Deviation 25.766
|
29.43 h*ng/mL
Standard Deviation 5.0744
|
57.72 h*ng/mL
Standard Deviation 21.853
|
16.88 h*ng/mL
Standard Deviation 9.9205
|
17.22 h*ng/mL
Standard Deviation 8.8861
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=4 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=4 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=6 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 and Its Metabolites M1 and M2
TAK-925
|
925.3 h*ng/mL
Standard Deviation 296.03
|
200.7 h*ng/mL
Standard Deviation 13.216
|
88.45 h*ng/mL
Standard Deviation 13.682
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 and Its Metabolites M1 and M2
Metabolite M1
|
634.0 h*ng/mL
Standard Deviation 549.20
|
102.4 h*ng/mL
Standard Deviation 55.929
|
54.77 h*ng/mL
Standard Deviation 17.148
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 and Its Metabolites M1 and M2
Metabolite M2
|
27.99 h*ng/mL
Standard Deviation 28.284
|
3.816 h*ng/mL
Standard Deviation 0.60811
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=6 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=6 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=5 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=6 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
n=6 Participants
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
n=6 Participants
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
n=6 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
n=6 Participants
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
n=4 Participants
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M1 and M2
TAK-925
|
16.70 nanogram per milliliter (ng/mL)
Standard Deviation 2.8896
|
36.83 nanogram per milliliter (ng/mL)
Standard Deviation 4.3976
|
57.56 nanogram per milliliter (ng/mL)
Standard Deviation 8.2309
|
122.6 nanogram per milliliter (ng/mL)
Standard Deviation 13.014
|
235.2 nanogram per milliliter (ng/mL)
Standard Deviation 40.712
|
304.9 nanogram per milliliter (ng/mL)
Standard Deviation 50.702
|
344.5 nanogram per milliliter (ng/mL)
Standard Deviation 23.549
|
506.3 nanogram per milliliter (ng/mL)
Standard Deviation 87.027
|
278.4 nanogram per milliliter (ng/mL)
Standard Deviation 33.127
|
237.8 nanogram per milliliter (ng/mL)
Standard Deviation 25.695
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M1 and M2
Metabolite M1
|
8.458 nanogram per milliliter (ng/mL)
Standard Deviation 3.5972
|
19.50 nanogram per milliliter (ng/mL)
Standard Deviation 4.9426
|
31.82 nanogram per milliliter (ng/mL)
Standard Deviation 11.983
|
67.69 nanogram per milliliter (ng/mL)
Standard Deviation 20.931
|
134.1 nanogram per milliliter (ng/mL)
Standard Deviation 45.828
|
189.2 nanogram per milliliter (ng/mL)
Standard Deviation 60.185
|
197.8 nanogram per milliliter (ng/mL)
Standard Deviation 26.011
|
333.2 nanogram per milliliter (ng/mL)
Standard Deviation 70.509
|
106.7 nanogram per milliliter (ng/mL)
Standard Deviation 30.612
|
114.4 nanogram per milliliter (ng/mL)
Standard Deviation 38.575
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M1 and M2
Metabolite M2
|
0.2379 nanogram per milliliter (ng/mL)
Standard Deviation 0.11806
|
0.4290 nanogram per milliliter (ng/mL)
Standard Deviation 0.24813
|
0.7051 nanogram per milliliter (ng/mL)
Standard Deviation 0.33672
|
1.076 nanogram per milliliter (ng/mL)
Standard Deviation 0.63619
|
2.564 nanogram per milliliter (ng/mL)
Standard Deviation 2.0370
|
3.422 nanogram per milliliter (ng/mL)
Standard Deviation 2.4880
|
3.279 nanogram per milliliter (ng/mL)
Standard Deviation 0.53902
|
6.611 nanogram per milliliter (ng/mL)
Standard Deviation 2.2350
|
1.751 nanogram per milliliter (ng/mL)
Standard Deviation 0.90125
|
2.022 nanogram per milliliter (ng/mL)
Standard Deviation 0.99882
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=4 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=4 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=6 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M1 and M2
TAK-925
|
96.48 ng/mL
Standard Deviation 21.981
|
21.86 ng/mL
Standard Deviation 2.5303
|
10.10 ng/mL
Standard Deviation 1.9527
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M1 and M2
Metabolite M1
|
64.28 ng/mL
Standard Deviation 39.990
|
11.23 ng/mL
Standard Deviation 5.0467
|
5.990 ng/mL
Standard Deviation 1.8931
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M1 and M2
Metabolite M2
|
1.305 ng/mL
Standard Deviation 1.9483
|
0.4884 ng/mL
Standard Deviation 0.28306
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=6 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=6 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=5 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=6 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
n=6 Participants
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
n=6 Participants
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
n=6 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
n=6 Participants
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
n=4 Participants
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1, Ceoi: Concentration at the End of Infusion for TAK-925 and Its Metabolites M1 and M2
TAK-925
|
13.37 ng/mL
Standard Deviation 2.0174
|
29.81 ng/mL
Standard Deviation 4.2579
|
52.08 ng/mL
Standard Deviation 7.2344
|
114.6 ng/mL
Standard Deviation 13.303
|
213.8 ng/mL
Standard Deviation 31.714
|
290.3 ng/mL
Standard Deviation 32.096
|
324.0 ng/mL
Standard Deviation 30.182
|
493.2 ng/mL
Standard Deviation 70.335
|
272.2 ng/mL
Standard Deviation 36.985
|
183.5 ng/mL
Standard Deviation 15.875
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1, Ceoi: Concentration at the End of Infusion for TAK-925 and Its Metabolites M1 and M2
Metabolite M1
|
7.532 ng/mL
Standard Deviation 3.4019
|
17.79 ng/mL
Standard Deviation 4.9179
|
28.06 ng/mL
Standard Deviation 11.208
|
58.79 ng/mL
Standard Deviation 23.607
|
121.3 ng/mL
Standard Deviation 37.632
|
167.5 ng/mL
Standard Deviation 58.242
|
174.0 ng/mL
Standard Deviation 20.376
|
295.5 ng/mL
Standard Deviation 75.002
|
98.82 ng/mL
Standard Deviation 31.862
|
105.0 ng/mL
Standard Deviation 38.567
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1, Ceoi: Concentration at the End of Infusion for TAK-925 and Its Metabolites M1 and M2
Metabolite M2
|
0.2289 ng/mL
Standard Deviation 0.12885
|
0.3978 ng/mL
Standard Deviation 0.23853
|
0.5928 ng/mL
Standard Deviation 0.27538
|
0.9225 ng/mL
Standard Deviation 0.54081
|
2.217 ng/mL
Standard Deviation 1.6608
|
3.079 ng/mL
Standard Deviation 2.3329
|
2.850 ng/mL
Standard Deviation 0.52592
|
4.868 ng/mL
Standard Deviation 2.3897
|
1.528 ng/mL
Standard Deviation 0.87452
|
1.624 ng/mL
Standard Deviation 0.96722
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=4 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=4 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=6 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2, Ceoi: Concentration at the End of Infusion for TAK-925 and Its Metabolites M1 and M2
TAK-925
|
94.04 ng/mL
Standard Deviation 23.643
|
21.17 ng/mL
Standard Deviation 1.7896
|
9.649 ng/mL
Standard Deviation 1.1339
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2, Ceoi: Concentration at the End of Infusion for TAK-925 and Its Metabolites M1 and M2
Metabolite M1
|
58.61 ng/mL
Standard Deviation 42.471
|
9.916 ng/mL
Standard Deviation 5.6434
|
5.412 ng/mL
Standard Deviation 1.7517
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2, Ceoi: Concentration at the End of Infusion for TAK-925 and Its Metabolites M1 and M2
Metabolite M2
|
1.075 ng/mL
Standard Deviation 1.8500
|
0.4037 ng/mL
Standard Deviation 0.23357
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=6 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=6 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=5 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=6 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
n=6 Participants
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
n=6 Participants
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
n=6 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
n=6 Participants
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
n=4 Participants
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M1 and M2
TAK-925
|
3.000 hours
Interval 2.0 to 4.0
|
4.000 hours
Interval 3.0 to 4.0
|
3.000 hours
Interval 2.0 to 4.0
|
4.000 hours
Interval 3.0 to 9.0
|
4.000 hours
Interval 1.5 to 9.0
|
6.500 hours
Interval 3.0 to 9.0
|
6.500 hours
Interval 3.0 to 9.0
|
4.000 hours
Interval 3.0 to 9.0
|
6.500 hours
Interval 1.5 to 9.0
|
5.000 hours
Interval 3.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M1 and M2
Metabolite M1
|
6.000 hours
Interval 6.0 to 9.0
|
6.000 hours
Interval 6.0 to 9.0
|
6.000 hours
Interval 6.0 to 8.0
|
6.000 hours
Interval 6.0 to 9.0
|
6.000 hours
Interval 6.0 to 9.0
|
6.000 hours
Interval 6.0 to 8.0
|
6.000 hours
Interval 6.0 to 6.0
|
6.000 hours
Interval 6.0 to 6.0
|
6.000 hours
Interval 6.0 to 6.0
|
8.000 hours
Interval 8.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M1 and M2
Metabolite M2
|
7.500 hours
Interval 4.0 to 9.0
|
8.000 hours
Interval 6.0 to 9.0
|
4.000 hours
Interval 4.0 to 4.0
|
6.000 hours
Interval 4.0 to 9.0
|
4.000 hours
Interval 3.0 to 6.0
|
4.000 hours
Interval 4.0 to 8.0
|
5.000 hours
Interval 4.0 to 6.0
|
3.500 hours
Interval 3.0 to 6.0
|
3.000 hours
Interval 1.5 to 9.0
|
3.500 hours
Interval 1.5 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=4 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=4 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=6 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M1 and M2
TAK-925
|
6.500 hours
Interval 4.0 to 9.0
|
9.000 hours
Interval 4.0 to 9.0
|
9.000 hours
Interval 4.0 to 9.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M1 and M2
Metabolite M1
|
6.000 hours
Interval 6.0 to 9.0
|
6.000 hours
Interval 6.0 to 9.0
|
6.000 hours
Interval 6.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M1 and M2
Metabolite M2
|
5.960 hours
Interval 4.0 to 9.0
|
5.990 hours
Interval 5.98 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=6 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=6 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=5 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=6 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
n=6 Participants
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
n=6 Participants
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
n=6 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
n=6 Participants
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
n=4 Participants
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1, t1/2z: Terminal Disposition Phase Half-life of TAK-925 and Its Metabolites M1 and M2
TAK-925
|
4.120 hours
Standard Deviation 1.9190
|
4.498 hours
Standard Deviation 1.7725
|
5.142 hours
Standard Deviation 1.8060
|
3.860 hours
Standard Deviation 0.6478
|
3.788 hours
Standard Deviation 1.0424
|
3.943 hours
Standard Deviation 0.9492
|
3.363 hours
Standard Deviation 0.8523
|
4.033 hours
Standard Deviation 1.2843
|
4.345 hours
Standard Deviation 0.5901
|
4.490 hours
Standard Deviation 1.5939
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1, t1/2z: Terminal Disposition Phase Half-life of TAK-925 and Its Metabolites M1 and M2
Metabolite M1
|
2.598 hours
Standard Deviation 1.3239
|
3.443 hours
Standard Deviation 0.9386
|
3.122 hours
Standard Deviation 0.4673
|
2.760 hours
Standard Deviation 0.8950
|
3.075 hours
Standard Deviation 0.5984
|
2.825 hours
Standard Deviation 0.5203
|
2.205 hours
Standard Deviation 0.2616
|
2.637 hours
Standard Deviation 0.5575
|
3.763 hours
Standard Deviation 0.7675
|
2.400 hours
Standard Deviation 0.6307
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1, t1/2z: Terminal Disposition Phase Half-life of TAK-925 and Its Metabolites M1 and M2
Metabolite M2
|
2.670 hours
|
1.8975 hours
Standard Deviation 0.2583
|
1.545 hours
Standard Deviation 0.1237
|
1.692 hours
Standard Deviation 0.7082
|
2.158 hours
Standard Deviation 0.7646
|
2.847 hours
Standard Deviation 1.5995
|
1.702 hours
Standard Deviation 0.4891
|
2.818 hours
Standard Deviation 1.0856
|
2.727 hours
Standard Deviation 1.3977
|
1.205 hours
Standard Deviation 0.2873
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=4 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=4 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=6 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2, t1/2z: Terminal Disposition Phase Half-life of TAK-925 and Its Metabolites M1 and M2
TAK-925
|
4.130 hours
Standard Deviation 1.1981
|
3.923 hours
Standard Deviation 1.0265
|
3.465 hours
Standard Deviation 1.0998
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
|
Part 2, t1/2z: Terminal Disposition Phase Half-life of TAK-925 and Its Metabolites M1 and M2
Metabolite M1
|
3.670 hours
Standard Deviation 0.9131
|
2.523 hours
Standard Deviation 1.0892
|
2.154 hours
Standard Deviation 0.4215
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2, t1/2z: Terminal Disposition Phase Half-life of TAK-925 and Its Metabolites M1 and M2
Metabolite M2
|
4.120 hours
Standard Deviation 2.5032
|
0.915 hours
Standard Deviation 0.2192
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "overall participants analyzed" are participants who were available for this outcome measure assessment at given time period.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=5 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=6 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=5 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=6 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
n=6 Participants
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
n=6 Participants
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
n=6 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
n=6 Participants
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
n=4 Participants
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1, Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-925
|
82.88 liter
Standard Deviation 29.543
|
77.07 liter
Standard Deviation 22.804
|
116.1 liter
Standard Deviation 35.215
|
91.40 liter
Standard Deviation 14.122
|
97.83 liter
Standard Deviation 22.194
|
88.47 liter
Standard Deviation 12.476
|
90.75 liter
Standard Deviation 24.140
|
97.48 liter
Standard Deviation 28.378
|
99.48 liter
Standard Deviation 15.472
|
77.98 liter
Standard Deviation 28.931
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "overall participants analyzed" are participants who were available for this outcome measure assessment at given time period.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=4 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=4 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=4 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2, Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-925
|
116.8 liter
Standard Deviation 7.8049
|
114.1 liter
Standard Deviation 14.964
|
111.7 liter
Standard Deviation 26.464
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "overall participants analyzed" are participants who were available for this outcome measure assessment at given time period.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=5 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=6 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=5 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=6 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
n=6 Participants
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
n=6 Participants
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
n=6 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
n=6 Participants
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
n=4 Participants
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1, Vz: Volume of Distribution During the Terminal Phase After Intravenous Administration for TAK-925
|
292.2 liter
Standard Deviation 124.03
|
271.7 liter
Standard Deviation 79.238
|
391.8 liter
Standard Deviation 117.09
|
290.7 liter
Standard Deviation 31.156
|
288.8 liter
Standard Deviation 55.185
|
284.7 liter
Standard Deviation 65.265
|
290.8 liter
Standard Deviation 77.783
|
313.0 liter
Standard Deviation 128.81
|
271.5 liter
Standard Deviation 39.145
|
357.3 liter
Standard Deviation 121.15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "overall participants analyzed" are participants who were available for this outcome measure assessment at given time period.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=4 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=4 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=4 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2, Vz: Volume of Distribution During the Terminal Phase After Intravenous Administration for TAK-925
|
281.3 liter
Standard Deviation 35.855
|
316.8 liter
Standard Deviation 84.263
|
282.3 liter
Standard Deviation 88.729
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 9 hours after the start of infusion and at 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 10 and 15 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "overall participants analyzed" are participants who were available for this outcome measure assessment at given time period.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=5 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=6 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=5 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=6 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
n=6 Participants
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
n=6 Participants
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
n=6 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
n=6 Participants
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
n=4 Participants
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1, CL: Total Clearance After Intravenous Administration for TAK-925
|
50.00 liter per hour (L/h)
Standard Deviation 9.0785
|
43.07 liter per hour (L/h)
Standard Deviation 6.4856
|
54.20 liter per hour (L/h)
Standard Deviation 9.9541
|
53.10 liter per hour (L/h)
Standard Deviation 8.2202
|
54.10 liter per hour (L/h)
Standard Deviation 9.0437
|
50.90 liter per hour (L/h)
Standard Deviation 9.8018
|
59.83 liter per hour (L/h)
Standard Deviation 3.3381
|
52.78 liter per hour (L/h)
Standard Deviation 7.4882
|
43.50 liter per hour (L/h)
Standard Deviation 4.9651
|
55.40 liter per hour (L/h)
Standard Deviation 5.2211
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1-4 pre-infusion and at 1, 2, 4, 6 and 9 hours after the start of infusion and at 0.17, 0.5, 1, 2 and 15 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "overall participants analyzed" are participants who were available for this outcome measure assessment at given time period.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=4 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=4 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=4 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2, CL: Total Clearance After Intravenous Administration for TAK-925
|
50.18 L/h
Standard Deviation 15.533
|
55.90 L/h
Standard Deviation 3.7692
|
57.05 L/h
Standard Deviation 9.5577
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and 0-9 hours after the start of infusion and at 0-3, 3-6, 6-15 and 15-24 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "overall participants analyzed" are participants who were available for this outcome measure assessment at given time period.
Urine assessments were done only in Part 1, as planned.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=5 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=6 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=5 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=6 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
n=6 Participants
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
n=6 Participants
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
n=6 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
n=6 Participants
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
n=4 Participants
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1, Ae(0-24): Amount of TAK-925 and Its Metabolites M1 and M2 Excreted in Urine From Time 0 to Time 24
TAK-925
|
1.892 microgram (mcg)
Standard Deviation 0.93889
|
5.460 microgram (mcg)
Standard Deviation 3.4291
|
14.10 microgram (mcg)
Standard Deviation 2.4515
|
60.87 microgram (mcg)
Standard Deviation 23.008
|
210.5 microgram (mcg)
Standard Deviation 75.775
|
335.8 microgram (mcg)
Standard Deviation 117.81
|
578.5 microgram (mcg)
Standard Deviation 110.30
|
1223 microgram (mcg)
Standard Deviation 76.855
|
214.3 microgram (mcg)
Standard Deviation 137.61
|
184.8 microgram (mcg)
Standard Deviation 53.662
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1, Ae(0-24): Amount of TAK-925 and Its Metabolites M1 and M2 Excreted in Urine From Time 0 to Time 24
Metabolite M1
|
198.8 microgram (mcg)
Standard Deviation 49.600
|
426.7 microgram (mcg)
Standard Deviation 101.25
|
792.8 microgram (mcg)
Standard Deviation 253.36
|
1697 microgram (mcg)
Standard Deviation 495.32
|
1905 microgram (mcg)
Standard Deviation 1490.9
|
5228 microgram (mcg)
Standard Deviation 1785.9
|
5815 microgram (mcg)
Standard Deviation 1095.4
|
8163 microgram (mcg)
Standard Deviation 945.57
|
2343 microgram (mcg)
Standard Deviation 635.69
|
3193 microgram (mcg)
Standard Deviation 677.37
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1, Ae(0-24): Amount of TAK-925 and Its Metabolites M1 and M2 Excreted in Urine From Time 0 to Time 24
Metabolite M2
|
0.000 microgram (mcg)
Standard Deviation 0.0000
|
1.152 microgram (mcg)
Standard Deviation 1.5202
|
2.438 microgram (mcg)
Standard Deviation 2.2612
|
8.695 microgram (mcg)
Standard Deviation 5.3533
|
31.25 microgram (mcg)
Standard Deviation 26.282
|
40.08 microgram (mcg)
Standard Deviation 28.904
|
43.12 microgram (mcg)
Standard Deviation 8.4203
|
79.90 microgram (mcg)
Standard Deviation 23.679
|
14.37 microgram (mcg)
Standard Deviation 6.0079
|
21.01 microgram (mcg)
Standard Deviation 10.331
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and 0-9 hours after the start of infusion and at 0-3, 3-6, 6-15 and 15-24 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "overall participants analyzed" are participants who were available for this outcome measure assessment at given time period.
Urine assessments were done only in Part 1, as planned.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=5 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=6 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=5 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=6 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
n=6 Participants
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
n=6 Participants
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
n=6 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
n=6 Participants
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
n=4 Participants
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1, Fe(0-24): Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time 24 for TAK-925 and Its Metabolites M1 and M2
TAK-925
|
0.028 percentage of dose
Standard Deviation 0.0148
|
0.038 percentage of dose
Standard Deviation 0.0232
|
0.050 percentage of dose
Standard Deviation 0.0071
|
0.110 percentage of dose
Standard Deviation 0.0424
|
0.190 percentage of dose
Standard Deviation 0.0657
|
0.250 percentage of dose
Standard Deviation 0.0883
|
0.322 percentage of dose
Standard Deviation 0.0624
|
0.508 percentage of dose
Standard Deviation 0.0319
|
0.192 percentage of dose
Standard Deviation 0.1237
|
0.165 percentage of dose
Standard Deviation 0.0480
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1, Fe(0-24): Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time 24 for TAK-925 and Its Metabolites M1 and M2
Metabolite M1
|
2.736 percentage of dose
Standard Deviation 0.6841
|
2.938 percentage of dose
Standard Deviation 0.6950
|
2.726 percentage of dose
Standard Deviation 0.8677
|
2.920 percentage of dose
Standard Deviation 0.8519
|
3.358 percentage of dose
Standard Deviation 1.2922
|
3.748 percentage of dose
Standard Deviation 1.2809
|
3.112 percentage of dose
Standard Deviation 0.5872
|
3.280 percentage of dose
Standard Deviation 0.3788
|
2.015 percentage of dose
Standard Deviation 0.5452
|
2.748 percentage of dose
Standard Deviation 0.5871
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1, Fe(0-24): Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time 24 for TAK-925 and Its Metabolites M1 and M2
Metabolite M2
|
0.000 percentage of dose
Standard Deviation 0.0000
|
0.008 percentage of dose
Standard Deviation 0.0117
|
0.008 percentage of dose
Standard Deviation 0.0084
|
0.017 percentage of dose
Standard Deviation 0.0103
|
0.025 percentage of dose
Standard Deviation 0.0243
|
0.028 percentage of dose
Standard Deviation 0.0214
|
0.023 percentage of dose
Standard Deviation 0.0052
|
0.032 percentage of dose
Standard Deviation 0.0117
|
0.013 percentage of dose
Standard Deviation 0.0082
|
0.018 percentage of dose
Standard Deviation 0.0096
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-infusion and 0-9 hours after the start of infusion and at 0-3, 3-6 and 6-15 hours post-infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated. Here "number analyzed" were participants who were evaluable for the outcome measure at given time points.
Urine assessments were done only in Part 1, as planned.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=6 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=6 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=5 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=6 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
n=6 Participants
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
n=6 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
n=6 Participants
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
n=6 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
n=6 Participants
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
n=4 Participants
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1, CLR: Renal Clearance of TAK-925 and Its Metabolites M1 and M2
TAK-925
|
0.01390 L/h
Standard Deviation 0.0071503
|
0.01656 L/h
Standard Deviation 0.0097578
|
0.02746 L/h
Standard Deviation 0.0053337
|
0.05672 L/h
Standard Deviation 0.018842
|
0.1020 L/h
Standard Deviation 0.037350
|
0.1275 L/h
Standard Deviation 0.046864
|
0.1928 L/h
Standard Deviation 0.035244
|
0.2705 L/h
Standard Deviation 0.031501
|
0.08337 L/h
Standard Deviation 0.053779
|
0.09053 L/h
Standard Deviation 0.018093
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1, CLR: Renal Clearance of TAK-925 and Its Metabolites M1 and M2
Metabolite M1
|
2.664 L/h
Standard Deviation 0.83930
|
2.438 L/h
Standard Deviation 0.30142
|
2.614 L/h
Standard Deviation 0.54500
|
2.653 L/h
Standard Deviation 0.24138
|
2.952 L/h
Standard Deviation 0.65615
|
2.878 L/h
Standard Deviation 0.35459
|
3.285 L/h
Standard Deviation 0.49152
|
2.643 L/h
Standard Deviation 0.37012
|
2.205 L/h
Standard Deviation 0.35172
|
3.173 L/h
Standard Deviation 0.50684
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1, CLR: Renal Clearance of TAK-925 and Its Metabolites M1 and M2
Metabolite M2
|
0.000 L/h
Standard Deviation 0.0000
|
0.2182 L/h
Standard Deviation 0.25950
|
0.4630 L/h
Standard Deviation 0.31605
|
0.7897 L/h
Standard Deviation 0.077544
|
1.014 L/h
Standard Deviation 0.23516
|
1.041 L/h
Standard Deviation 0.12104
|
1.468 L/h
Standard Deviation 0.20508
|
1.353 L/h
Standard Deviation 0.12894
|
0.7967 L/h
Standard Deviation 0.15368
|
1.132 L/h
Standard Deviation 0.24401
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 at 6 hours after start of infusionPopulation: The PK analysis set was defined as all participants who received at least one dose of study drug and whose plasma or CSF concentration was measured at least once or whose cumulative urinary excretion was calculated.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=4 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1, R(CSF/Plasma,ss): Cerebrospinal Fluid/Plasma Drug Concentration at Steady State for TAK-925 and Its Metabolites M1 and M2 in Cohort 4
TAK-925
|
0.02848 Ratio
Standard Deviation 0.0056258
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1, R(CSF/Plasma,ss): Cerebrospinal Fluid/Plasma Drug Concentration at Steady State for TAK-925 and Its Metabolites M1 and M2 in Cohort 4
Metabolite M1
|
0.06190 Ratio
Standard Deviation 0.010358
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1, R(CSF/Plasma,ss): Cerebrospinal Fluid/Plasma Drug Concentration at Steady State for TAK-925 and Its Metabolites M1 and M2 in Cohort 4
Metabolite M2
|
0.02818 Ratio
Standard Deviation 0.032718
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 3 up to 8 hours following the start of infusionPopulation: The pharmacodynamic analysis set was defined as all participants who received at least one dose of study drug.
The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake.
Outcome measures
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=13 Participants
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=4 Participants
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=4 Participants
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=6 Participants
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Par 1 Cohort 2: TAK-925 56 mg
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
Part 2 Cohort 5-7: Pooled Placebo
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Average Sleep Latency in Maintenance of Wakefulness Test (MWT)
|
2.88 minutes
Standard Deviation 1.646
|
40.00 minutes
Standard Deviation 0.000
|
37.59 minutes
Standard Deviation 4.813
|
22.38 minutes
Standard Deviation 10.125
|
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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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|
—
|
—
|
—
|
—
|
Adverse Events
Part 2 Cohort 5-7: Pooled Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2 Cohort 5: TAK-925 44.8 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2 Cohort 6: TAK-925 11.2 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2 Cohort 7: TAK-925 5 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1 Cohort 1-2: Pooled Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 Cohort 1: TAK-925 7 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 Cohort 2: TAK-925 14 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 Cohort 1: TAK-925 28 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Par 1 Cohort 2: TAK-925 56 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 Cohort 1: TAK-925 112 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 Cohort 2: TAK-925 134.4 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 Cohort S1-S2: Pooled Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 Cohort S1: TAK-925 180 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 Cohort S2: TAK-925 240 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1 Cohort 3: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1 Cohort 3: TAK-925 112 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 Cohort 4: TAK-925 112 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 2 Cohort 5-7: Pooled Placebo
n=13 participants at risk
TAK-925 placebo-matching infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy in Cohort 5 to 7 under 2-period crossover design.
|
Part 2 Cohort 5: TAK-925 44.8 mg
n=4 participants at risk
TAK-925 44.8 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 6: TAK-925 11.2 mg
n=4 participants at risk
TAK-925 11.2 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 2 Cohort 7: TAK-925 5 mg
n=6 participants at risk
TAK-925 5 mg, infusion, intravenously, once on Day 1 or Day 3 in participants with type 1 narcolepsy under 2-period crossover design.
|
Part 1 Cohort 1-2: Pooled Placebo
n=11 participants at risk
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in Group A to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 7 mg
n=6 participants at risk
TAK-925 7 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 14 mg
n=6 participants at risk
TAK-925 14 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 28 mg
n=5 participants at risk
TAK-925 28 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Par 1 Cohort 2: TAK-925 56 mg
n=6 participants at risk
TAK-925 56 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort 1: TAK-925 112 mg
n=6 participants at risk
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in Group A to D in double-blind, alternating panel.
|
Part 1 Cohort 2: TAK-925 134.4 mg
n=6 participants at risk
TAK-925 134.4 mg, infusion, intravenously, once on Day 1 in healthy adults in Group E to H in double-blind, alternating panel.
|
Part 1 Cohort S1-S2: Pooled Placebo
n=4 participants at risk
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S1: TAK-925 180 mg
n=6 participants at risk
TAK-925 180 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort S2: TAK-925 240 mg
n=6 participants at risk
TAK-925 240 mg, infusion, intravenously, once on Day 1 in healthy adults in double-blind, parallel group.
|
Part 1 Cohort 3: Placebo
n=2 participants at risk
TAK-925 placebo-matching infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 3: TAK-925 112 mg
n=6 participants at risk
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy elderly participants in double-blind, parallel group.
|
Part 1 Cohort 4: TAK-925 112 mg
n=4 participants at risk
TAK-925 112 mg, infusion, intravenously, once on Day 1 in healthy adults in unblinded manner.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
|
General disorders
Feeling drunk
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
|
Infections and infestations
Influenza
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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
Blood pressure increased
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
9.1%
1/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
20.0%
1/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
2/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
2/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
4/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
50.0%
3/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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
Electrocardiogram PR prolongation
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
2/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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
Heart rate increased
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
20.0%
1/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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
Blood triglycerides increased
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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
White blood cell count increased
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
9.1%
1/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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
Oropharyngeal pain
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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
C-reactive protein increased
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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
Dizziness
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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
Salivary hypersecretion
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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
Narcolepsy
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
|
Psychiatric disorders
Hypnagogic hallucination
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
|
Psychiatric disorders
Logorrhoea
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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
Cough
|
0.00%
0/13 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 7 days (Day 7) after the last dose of study drug
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