Trial Outcomes & Findings for A Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics of TAK-117 (MLN1117) in Healthy Participants (NCT NCT02625259)
NCT ID: NCT02625259
Last Updated: 2018-01-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
54 participants
Primary outcome timeframe
Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose
Results posted on
2018-01-08
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 08 January 2016 to 22 July 2016.
Healthy participants were enrolled in this 3-part study to receive TAK-117 in Part 1 as: Crossover of 9\*100 milligram (mg) capsules or 3\*300 mg tablets, Part 2: Crossover of TAK-117 in fasted or fed state and Part 3: TAK-117 with lansoprazole.
Participant milestones
| Measure |
Part-1: TAK-117 900 mg Capsules + TAK-117 900 mg Tablets
TAK-117 9\*100 mg, capsules (current clinical trial material \[CTM\]), orally, once on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 3\*300 mg, tablets (new clinical trial material \[NTM\]), orally, once on Day 15 (second intervention).
|
Part-1: TAK-117 900 mg Tablets + TAK-117 900 mg Capsules
TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 9\*100 mg, capsules (CTM), orally, once on Day 15 (second intervention).
|
Part-2: TAK-117 600 mg Fasted + TAK-117 600 mg Fed
TAK-117 2\*300 mg, tablets (NTM), orally, once in the fasted state on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 2\*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 15 (second intervention).
|
Part-2: TAK-117 600 mg Fed + TAK-117 600 mg Fasted
TAK-117 2\*300 mg, tablets (NTM), orally, once with a standard high-fat breakfast on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 2\*300 mg, tablets (NTM), orally, in the fasted state, once on Day 15 (second intervention).
|
Part-3: TAK-117 900 mg + Lansoprazole 30 mg
TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1, followed by lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 15 along with TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 15 approximately 1 hour (hr) after the last dose of lansoprazole 30 mg.
|
|---|---|---|---|---|---|
|
First Intervention (Day 1)
STARTED
|
11
|
9
|
8
|
10
|
16
|
|
First Intervention (Day 1)
COMPLETED
|
9
|
8
|
7
|
9
|
16
|
|
First Intervention (Day 1)
NOT COMPLETED
|
2
|
1
|
1
|
1
|
0
|
|
Washout (Day 2 to Day 14)
STARTED
|
9
|
8
|
7
|
9
|
0
|
|
Washout (Day 2 to Day 14)
COMPLETED
|
9
|
8
|
7
|
9
|
0
|
|
Washout (Day 2 to Day 14)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention (Day 15)
STARTED
|
9
|
8
|
7
|
9
|
0
|
|
Second Intervention (Day 15)
COMPLETED
|
9
|
8
|
7
|
9
|
0
|
|
Second Intervention (Day 15)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part-1: TAK-117 900 mg Capsules + TAK-117 900 mg Tablets
TAK-117 9\*100 mg, capsules (current clinical trial material \[CTM\]), orally, once on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 3\*300 mg, tablets (new clinical trial material \[NTM\]), orally, once on Day 15 (second intervention).
|
Part-1: TAK-117 900 mg Tablets + TAK-117 900 mg Capsules
TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 9\*100 mg, capsules (CTM), orally, once on Day 15 (second intervention).
|
Part-2: TAK-117 600 mg Fasted + TAK-117 600 mg Fed
TAK-117 2\*300 mg, tablets (NTM), orally, once in the fasted state on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 2\*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 15 (second intervention).
|
Part-2: TAK-117 600 mg Fed + TAK-117 600 mg Fasted
TAK-117 2\*300 mg, tablets (NTM), orally, once with a standard high-fat breakfast on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 2\*300 mg, tablets (NTM), orally, in the fasted state, once on Day 15 (second intervention).
|
Part-3: TAK-117 900 mg + Lansoprazole 30 mg
TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1, followed by lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 15 along with TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 15 approximately 1 hour (hr) after the last dose of lansoprazole 30 mg.
|
|---|---|---|---|---|---|
|
First Intervention (Day 1)
Other
|
0
|
0
|
1
|
0
|
0
|
|
First Intervention (Day 1)
Adverse Event
|
2
|
1
|
0
|
0
|
0
|
|
First Intervention (Day 1)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics of TAK-117 (MLN1117) in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part-1: TAK-117 900 mg Capsules + TAK-117 900 mg Tablets
n=11 Participants
TAK-117 9\*100 mg, capsules (current clinical trial material \[CTM\]), orally, once on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 3\*300 mg, tablets (new clinical trial material \[NTM\]), orally, once on Day 15 (second intervention).
|
Part-1: TAK-117 900 mg Tablets + TAK-117 900 mg Capsules
n=9 Participants
TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 9\*100 mg, capsules (CTM), orally, once on Day 15 (second intervention).
|
Part-2: TAK-117 600 mg Fasted + TAK-117 600 mg Fed
n=8 Participants
TAK-117 2\*300 mg, tablets (NTM), orally, once in the fasted state on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 2\*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 15 (second intervention).
|
Part-2: TAK-117 600 mg Fed + TAK-117 600 mg Fasted
n=10 Participants
TAK-117 2\*300 mg, tablets (NTM), orally, once with a standard high-fat breakfast on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 2\*300 mg, tablets (NTM), orally, in the fasted state, once on Day 15 (second intervention).
|
Part-3: TAK-117 900 mg + Lansoprazole 30 mg
n=16 Participants
TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1, followed by lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 15 along with TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 15 approximately 1 hour (hr) after the last dose of lansoprazole 30 mg.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
18-45 years
|
11 participants
7.63 • n=5 Participants
|
9 participants
7.79 • n=7 Participants
|
8 participants
7.15 • n=5 Participants
|
10 participants
6.13 • n=4 Participants
|
16 participants
6.88 • n=21 Participants
|
54 participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
38 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
8 participants
n=5 Participants
|
10 participants
n=4 Participants
|
16 participants
n=21 Participants
|
54 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The pharmacokinetic (PK)-evaluable population included participants who received both doses of TAK-117 study drug in each sequence and had sufficient PK data to reliably estimate PK parameters that were used for PK analyses.
Outcome measures
| Measure |
Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules)
n=17 Participants
TAK-117 9\*100 mg, capsules (CTM), orally, once on Day 1 or 15 of intervention period.
|
Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets)
n=17 Participants
TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1 or 15 of intervention period.
|
Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets)
n=16 Participants
TAK-117 2\*300 mg, tablets (NTM), orally, once in a fasted state on Day 1 or 15 of intervention period.
|
Part-2: TAK-117 600 mg Fed (2*300 mg Tablets)
n=16 Participants
TAK-117 2\*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 1 or 15 of intervention period.
|
Part-3: TAK-117 900 mg (3*300 mg Tablets)
n=16 Participants
TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1.
|
Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg
n=16 Participants
Lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 15 along with TAK-117 3\*300 mg, tablets (NTM), orally once on Day 15.
|
|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-117
|
4632.992 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 71
|
6225.347 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 53
|
6455.111 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 48
|
7847.591 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 24
|
5859.156 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 58
|
190.172 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 144
|
PRIMARY outcome
Timeframe: Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The PK-evaluable population included participants who received both doses of TAK-117 study drug in each sequence and had sufficient PK data to reliably estimate PK parameters that were used for PK analyses.
Outcome measures
| Measure |
Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules)
n=17 Participants
TAK-117 9\*100 mg, capsules (CTM), orally, once on Day 1 or 15 of intervention period.
|
Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets)
n=17 Participants
TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1 or 15 of intervention period.
|
Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets)
n=16 Participants
TAK-117 2\*300 mg, tablets (NTM), orally, once in a fasted state on Day 1 or 15 of intervention period.
|
Part-2: TAK-117 600 mg Fed (2*300 mg Tablets)
n=16 Participants
TAK-117 2\*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 1 or 15 of intervention period.
|
Part-3: TAK-117 900 mg (3*300 mg Tablets)
n=16 Participants
TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1.
|
Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg
n=16 Participants
Lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 15 along with TAK-117 3\*300 mg, tablets (NTM), orally once on Day 15.
|
|---|---|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117
|
2.067 hours
Interval 1.0 to 6.0
|
3.000 hours
Interval 0.5 to 6.0
|
3.000 hours
Interval 2.0 to 6.07
|
6.033 hours
Interval 4.0 to 8.03
|
3.000 hours
Interval 1.0 to 6.0
|
3.517 hours
Interval 1.0 to 6.0
|
PRIMARY outcome
Timeframe: Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The PK-evaluable population included participants who received both doses of TAK-117 study drug in each sequence and had sufficient PK data to reliably estimate PK parameters that were used for PK analyses.
Outcome measures
| Measure |
Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules)
n=17 Participants
TAK-117 9\*100 mg, capsules (CTM), orally, once on Day 1 or 15 of intervention period.
|
Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets)
n=17 Participants
TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1 or 15 of intervention period.
|
Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets)
n=16 Participants
TAK-117 2\*300 mg, tablets (NTM), orally, once in a fasted state on Day 1 or 15 of intervention period.
|
Part-2: TAK-117 600 mg Fed (2*300 mg Tablets)
n=16 Participants
TAK-117 2\*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 1 or 15 of intervention period.
|
Part-3: TAK-117 900 mg (3*300 mg Tablets)
n=16 Participants
TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1.
|
Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg
n=16 Participants
Lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 15 along with TAK-117 3\*300 mg, tablets (NTM), orally once on Day 15.
|
|---|---|---|---|---|---|---|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-117
|
45727.280 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 94
|
66015.952 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 91
|
71442.968 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 67
|
127143.511 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 39
|
63165.064 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 91
|
1018.650 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 129
|
PRIMARY outcome
Timeframe: Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The PK-evaluable population where data at specified time points were available. The PK-evaluable population included participants who received both doses of TAK-117 study drug in each sequence and had sufficient PK data to reliably estimate PK parameters that were used for PK analyses.
Outcome measures
| Measure |
Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules)
n=13 Participants
TAK-117 9\*100 mg, capsules (CTM), orally, once on Day 1 or 15 of intervention period.
|
Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets)
n=13 Participants
TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1 or 15 of intervention period.
|
Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets)
n=15 Participants
TAK-117 2\*300 mg, tablets (NTM), orally, once in a fasted state on Day 1 or 15 of intervention period.
|
Part-2: TAK-117 600 mg Fed (2*300 mg Tablets)
n=16 Participants
TAK-117 2\*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 1 or 15 of intervention period.
|
Part-3: TAK-117 900 mg (3*300 mg Tablets)
n=15 Participants
TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1.
|
Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg
n=4 Participants
Lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 15 along with TAK-117 3\*300 mg, tablets (NTM), orally once on Day 15.
|
|---|---|---|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-117
|
64165.340 ng*hr/mL
Geometric Coefficient of Variation 77
|
96293.083 ng*hr/mL
Geometric Coefficient of Variation 77
|
81595.634 ng*hr/mL
Geometric Coefficient of Variation 61
|
128336.896 ng*hr/mL
Geometric Coefficient of Variation 39
|
85782.122 ng*hr/mL
Geometric Coefficient of Variation 85
|
6547.254 ng*hr/mL
Geometric Coefficient of Variation 66
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dosePopulation: The PK-evaluable population included participants who received both doses of TAK-117 study drug in each sequence and had sufficient PK data to reliably estimate PK parameters that were used for PK analyses.
Outcome measures
| Measure |
Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules)
n=17 Participants
TAK-117 9\*100 mg, capsules (CTM), orally, once on Day 1 or 15 of intervention period.
|
Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets)
n=17 Participants
TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1 or 15 of intervention period.
|
Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets)
TAK-117 2\*300 mg, tablets (NTM), orally, once in a fasted state on Day 1 or 15 of intervention period.
|
Part-2: TAK-117 600 mg Fed (2*300 mg Tablets)
TAK-117 2\*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 1 or 15 of intervention period.
|
Part-3: TAK-117 900 mg (3*300 mg Tablets)
TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1.
|
Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg
Lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 15 along with TAK-117 3\*300 mg, tablets (NTM), orally once on Day 15.
|
|---|---|---|---|---|---|---|
|
Part 1: Renal Clearance (CLr) of TAK-117
|
0.314 liter per hour (L/hr)
Standard Deviation 0.1179
|
0.311 liter per hour (L/hr)
Standard Deviation 0.1304
|
—
|
—
|
—
|
—
|
Adverse Events
Part-1: TAK-117 900 mg Capsules
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part-1: TAK-117 900 mg Tablets
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part-2: TAK-117 600 mg Fasted
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part-2: TAK-117 600 mg Fed
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part-3: TAK-117 900 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part-3: Lansoprazole 30 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 3: Lansoprazole 30 mg + TAK-117 900 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-1: TAK-117 900 mg Capsules
n=19 participants at risk
TAK-117 9\*100 mg, capsules (CTM), orally, once on Day 1 or 15 of intervention period.
|
Part-1: TAK-117 900 mg Tablets
n=18 participants at risk
TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1 or 15 of intervention period.
|
Part-2: TAK-117 600 mg Fasted
n=17 participants at risk
TAK-117 2\*300 mg, tablets (NTM), orally, once in a fasted state on Day 1 or 15 of intervention period.
|
Part-2: TAK-117 600 mg Fed
n=17 participants at risk
TAK-117 2\*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 1 or 15 of intervention period.
|
Part-3: TAK-117 900 mg
n=16 participants at risk
TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1.
|
Part-3: Lansoprazole 30 mg
n=16 participants at risk
Lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 14.
|
Part 3: Lansoprazole 30 mg + TAK-117 900 mg
n=16 participants at risk
Lansoprazole 30 mg, capsule, orally, once daily on Day 15 along with TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 15.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
15.8%
3/19 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
16.7%
3/18 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
41.2%
7/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
23.5%
4/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
31.2%
5/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
3/19 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
11.1%
2/18 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
5.9%
1/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
5.9%
1/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
5.9%
1/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
1/19 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
Nervous system disorders
Dizziness
|
5.3%
1/19 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
5.9%
1/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
11.8%
2/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
12.5%
2/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
Nervous system disorders
Somnolence
|
5.3%
1/19 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
5.9%
1/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
Eye disorders
Vision blurred
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
5.9%
1/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
5.9%
1/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
5.9%
1/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
General disorders
Fatigue
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/17 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 46) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
- Publication restrictions are in place
Restriction type: OTHER