Trial Outcomes & Findings for Single-Dose Phase 1 Study of TAK-792 (NCT NCT02448719)
NCT ID: NCT02448719
Last Updated: 2019-03-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
72 participants
Primary outcome timeframe
Baseline up to Day 8
Results posted on
2019-03-19
Participant Flow
Participants took part in the study at 1 investigative site in Japan from 27 May 2015 to 28 January 2016.
Healthy Japanese participants received TAK-792 or placebo in Cohort 1a (30 milligram \[mg\]), Cohort 2a (100 mg), Cohort 3a (250 mg), Cohort 4a (500 mg), Cohort 5a (750 mg), and Cohort 6a (1250 mg). Healthy Caucasian participants received TAK-792 or placebo in Cohort 4b (500 mg), Cohort 5b (750 mg) and Cohort 6b (1250 mg).
Participant milestones
| Measure |
Cohort 1a-6a: Placebo
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 1a: TAK-792 30 mg
TAK-792 30 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 2a: TAK-792 100 mg
TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 3a: TAK-792 250 mg
TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4a: TAK-792 500 mg
TAK-792 500 mg, tablets, orally, once in fasted state (4a-1) on Day 1 of 5-day treatment period, in Japanese participants. Participants also received same medication later in fed state (4a-2) on Day 1 of another 5-day treatment period.
|
Cohort 5a: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state (5a-1), once on Day 1 of 5-day treatment period, in Japanese participants. Participants also received same medication later in fasted state (5a-2) on Day 1 of another 5-day treatment period.
|
Cohort 6a: TAK-792 1250 mg
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-6b: Placebo
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b: TAK-792 500 mg
TAK-792 500 mg, tablets, orally, once in fasted state (4b-1) on Day 1 of 5-day treatment period, in Caucasian participants. Participants also received same medication later in fed state (4b-2) on Day 1 of another 5-day treatment period.
|
Cohort 5b: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state (5b-1), once on Day 1 of 5-day treatment period, in Caucasian participants. Participants also received same medication later in fasted state (5b-2) on Day 1 of another 5-day treatment period.
|
Cohort 6b: TAK-792 1250 mg
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
12
|
6
|
6
|
6
|
5
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1a-6a: Placebo
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 1a: TAK-792 30 mg
TAK-792 30 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 2a: TAK-792 100 mg
TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 3a: TAK-792 250 mg
TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4a: TAK-792 500 mg
TAK-792 500 mg, tablets, orally, once in fasted state (4a-1) on Day 1 of 5-day treatment period, in Japanese participants. Participants also received same medication later in fed state (4a-2) on Day 1 of another 5-day treatment period.
|
Cohort 5a: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state (5a-1), once on Day 1 of 5-day treatment period, in Japanese participants. Participants also received same medication later in fasted state (5a-2) on Day 1 of another 5-day treatment period.
|
Cohort 6a: TAK-792 1250 mg
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-6b: Placebo
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b: TAK-792 500 mg
TAK-792 500 mg, tablets, orally, once in fasted state (4b-1) on Day 1 of 5-day treatment period, in Caucasian participants. Participants also received same medication later in fed state (4b-2) on Day 1 of another 5-day treatment period.
|
Cohort 5b: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state (5b-1), once on Day 1 of 5-day treatment period, in Caucasian participants. Participants also received same medication later in fasted state (5b-2) on Day 1 of another 5-day treatment period.
|
Cohort 6b: TAK-792 1250 mg
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Single-Dose Phase 1 Study of TAK-792
Baseline characteristics by cohort
| Measure |
Cohort 1a-6a: Placebo
n=12 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 1a: TAK-792 30 mg
n=6 Participants
TAK-792 30 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 2a: TAK-792 100 mg
n=6 Participants
TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 3a: TAK-792 250 mg
n=6 Participants
TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4a: TAK-792 500 mg
n=5 Participants
TAK-792 500 mg, tablets, orally, once in fasted state (4a-1) on Day 1 of 5-day treatment period, in Japanese participants. Participants also received same medication later in fed state (4a-2) on Day 1 of another 5-day treatment period.
|
Cohort 5a: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state (5a-1), once on Day 1 of 5-day treatment period, in Japanese participants. Participants also received same medication later in fasted state (5a-2) on Day 1 of another 5-day treatment period.
|
Cohort 6a: TAK-792 1250 mg
n=6 Participants
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-6b: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally, once in fasted state (4b-1) on Day 1 of 5-day treatment period, in Caucasian participants. Participants also received same medication later in fed state (4b-2) on Day 1 of another 5-day treatment period.
|
Cohort 5b: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state (5b-1), once on Day 1 of 5-day treatment period, in Caucasian participants. Participants also received same medication later in fasted state (5b-2) on Day 1 of another 5-day treatment period.
|
Cohort 6b: TAK-792 1250 mg
n=6 Participants
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
71 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
71 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
12 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
5 participants
n=21 Participants
|
6 participants
n=8 Participants
|
6 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
47 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
6 participants
n=24 Participants
|
6 participants
n=42 Participants
|
6 participants
n=42 Participants
|
6 participants
n=42 Participants
|
24 participants
n=42 Participants
|
|
Region of Enrollment
Japan
|
12 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
5 participants
n=21 Participants
|
6 participants
n=8 Participants
|
6 participants
n=8 Participants
|
6 participants
n=24 Participants
|
6 participants
n=42 Participants
|
6 participants
n=42 Participants
|
6 participants
n=42 Participants
|
71 participants
n=42 Participants
|
|
Smoking Classification
Never Smoked
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
42 Participants
n=42 Participants
|
|
Smoking Classification
Ex-Smoker
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
|
Alcohol Classification
Drank a few days per week
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Alcohol Classification
Drank a few days per month
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
46 Participants
n=42 Participants
|
|
Alcohol Classification
Did not drink
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
|
Caffeine Classification
Caffeine Consumption
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
|
Caffeine Classification
No Caffeine Consumption
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
45 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 8Population: Safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Cohort 4a-2: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=2 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1: TAK-792 500 mg
n=5 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 2a: TAK-792 100 mg
n=6 Participants
TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 3a: TAK-792 250 mg
n=6 Participants
TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 1a-6a: Placebo
n=12 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-1: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-2: Placebo
n=2 Participants
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1 - 6b: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-1: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 6b: TAK-792 1250 mg
n=6 Participants
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: Placebo
n=2 Participants
TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: Placebo
n=2 Participants
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
16.7 percentage of participants
|
0.0 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
0.0 percentage of participants
|
16.7 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
50.0 percentage of participants
|
33.3 percentage of participants
|
0.0 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
16.7 percentage of participants
|
0.0 percentage of participants
|
16.7 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 5Population: Safety analysis set included all participants who received at least 1 dose of study drug.
Vital signs included body temperature (infra-axillary measurement), supine blood pressure (systolic and diastolic) after the participant has rested for at least 5 minutes, respiratory rate, and pulse (beats per minute \[bpm\]).
Outcome measures
| Measure |
Cohort 4a-2: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=2 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1: TAK-792 500 mg
n=5 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 2a: TAK-792 100 mg
n=6 Participants
TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 3a: TAK-792 250 mg
n=6 Participants
TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 1a-6a: Placebo
n=12 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-1: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-2: Placebo
n=2 Participants
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1 - 6b: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-1: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 6b: TAK-792 1250 mg
n=6 Participants
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: Placebo
n=2 Participants
TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: Placebo
n=2 Participants
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAE Related to Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 5Population: Safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Cohort 4a-2: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=2 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1: TAK-792 500 mg
n=5 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 2a: TAK-792 100 mg
n=6 Participants
TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 3a: TAK-792 250 mg
n=6 Participants
TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 1a-6a: Placebo
n=12 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-1: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-2: Placebo
n=2 Participants
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1 - 6b: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-1: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 6b: TAK-792 1250 mg
n=6 Participants
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: Placebo
n=2 Participants
TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: Placebo
n=2 Participants
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAE Related to Body Weight
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 5Population: Safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Cohort 4a-2: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=2 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1: TAK-792 500 mg
n=5 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 2a: TAK-792 100 mg
n=6 Participants
TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 3a: TAK-792 250 mg
n=6 Participants
TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 1a-6a: Placebo
n=12 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-1: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-2: Placebo
n=2 Participants
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1 - 6b: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-1: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 6b: TAK-792 1250 mg
n=6 Participants
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: Placebo
n=2 Participants
TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: Placebo
n=2 Participants
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAE Related to Electrocardiograms (ECG)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 5Population: Safety analysis set included all participants who received at least 1 dose of study drug.
Reported TEAE Related to Laboratory Tests are following; Occult blood positive, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Blood creatine phosphokinase increased, Blood glucose increased, Blood triglycerides increased, Blood urine present, Protein urine present, and White blood cell count increased.
Outcome measures
| Measure |
Cohort 4a-2: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=2 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1: TAK-792 500 mg
n=5 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 2a: TAK-792 100 mg
n=6 Participants
TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 3a: TAK-792 250 mg
n=6 Participants
TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 1a-6a: Placebo
n=12 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-1: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-2: Placebo
n=2 Participants
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1 - 6b: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-1: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 6b: TAK-792 1250 mg
n=6 Participants
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: Placebo
n=2 Participants
TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: Placebo
n=2 Participants
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs Related to Laboratory Tests
Blood bilirubin increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Laboratory Tests
Blood creatine phosphokinase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Laboratory Tests
Alanine aminotransferase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Laboratory Tests
Aspartate aminotransferase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Laboratory Tests
Blood triglycerides increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Laboratory Tests
Blood urine present
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Laboratory Tests
Protein urine present
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Laboratory Tests
White blood cell count increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Related to Laboratory Tests
Occult blood positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With TEAEs Related to Laboratory Tests
Blood glucose increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 5Population: Safety analysis set included all participants who received at least 1 dose of study drug.
The gastrointestinal (GI) symptoms (abdominal pain, heartburn, acid regurgitation, hunger pains, nausea, borborygmus, abdominal distension, eructation, increased flatus, constipation, diarrhoea, loose stools, hard stools, urgent need for defecation, and feeling of incomplete evacuation) using GSRS questionnaires at each assessment point. The GSRS a 15-item self-administered questionnaire that assesses the impact of GI symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to GI symptoms. TEAEs related to GSRS were reported as follows: Diarrhoea, Constipation, Faeces hard, and Faeces soft.
Outcome measures
| Measure |
Cohort 4a-2: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=2 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1: TAK-792 500 mg
n=5 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 2a: TAK-792 100 mg
n=6 Participants
TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 3a: TAK-792 250 mg
n=6 Participants
TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 1a-6a: Placebo
n=12 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-1: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-2: Placebo
n=2 Participants
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1 - 6b: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-1: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 6b: TAK-792 1250 mg
n=6 Participants
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: Placebo
n=2 Participants
TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: Placebo
n=2 Participants
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS)
Diarrhoea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS)
Constipation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS)
Faeces hard
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS)
Faeces soft
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dosePopulation: PK analysis set included all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.
Outcome measures
| Measure |
Cohort 4a-2: TAK-792 500 mg
n=5 Participants
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 2a: TAK-792 100 mg
n=6 Participants
TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 3a: TAK-792 250 mg
n=6 Participants
TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 1a-6a: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=5 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-1: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-2: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1 - 6b: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-1: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 6b: TAK-792 1250 mg
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: Placebo
TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: TAK-792 500 mg
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: Placebo
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II
TAK-792F
|
357.2 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 44.5
|
898.6 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 28.5
|
610.5 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 28.3
|
350.0 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 15.7
|
521.3 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 24.6
|
47.34 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 24.7
|
770.6 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 36.4
|
998.5 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 53.2
|
1988.0 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 40.8
|
622.5 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 51.8
|
557.0 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 53.9
|
485.6 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 31.5
|
558.2 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 50.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II
M-I
|
79.70 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 34.2
|
190.5 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 51.3
|
133.6 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 39.5
|
84.01 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 40.8
|
63.94 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 51.7
|
6.765 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 25.9
|
128.1 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 27.7
|
167.6 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 43.1
|
424.2 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 41.9
|
224.0 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 34.7
|
407.9 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 40.7
|
97.17 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 36.6
|
177.6 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 41.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II
M-II
|
3237.0 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 66.9
|
5483.0 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 54.8
|
4824.0 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 38.4
|
1324.0 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 45.7
|
2658.0 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 57.9
|
422.5 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 22.1
|
3192.0 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 56.3
|
4909.0 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 56.2
|
5086.0 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 78.9
|
6261.0 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 51.1
|
15430.0 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 26.7
|
4813.0 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 32.9
|
7156.0 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 17.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dosePopulation: PK analysis set included all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.
Outcome measures
| Measure |
Cohort 4a-2: TAK-792 500 mg
n=5 Participants
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 2a: TAK-792 100 mg
n=6 Participants
TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 3a: TAK-792 250 mg
n=6 Participants
TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 1a-6a: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=5 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-1: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-2: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1 - 6b: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-1: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 6b: TAK-792 1250 mg
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: Placebo
TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: TAK-792 500 mg
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: Placebo
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II
TAK-792F
|
356.2 ng*hr/mL
Geometric Coefficient of Variation 44.6
|
891.9 ng*hr/mL
Geometric Coefficient of Variation 28.7
|
608.4 ng*hr/mL
Geometric Coefficient of Variation 28.4
|
346.6 ng*hr/mL
Geometric Coefficient of Variation 15.4
|
517.4 ng*hr/mL
Geometric Coefficient of Variation 24.8
|
46.45 ng*hr/mL
Geometric Coefficient of Variation 24.2
|
767.8 ng*hr/mL
Geometric Coefficient of Variation 36.6
|
995.9 ng*hr/mL
Geometric Coefficient of Variation 53.4
|
1980.0 ng*hr/mL
Geometric Coefficient of Variation 41.0
|
619.2 ng*hr/mL
Geometric Coefficient of Variation 51.8
|
554.9 ng*hr/mL
Geometric Coefficient of Variation 54.1
|
481.9 ng*hr/mL
Geometric Coefficient of Variation 31.8
|
553.6 ng*hr/mL
Geometric Coefficient of Variation 50.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II
M-I
|
74.37 ng*hr/mL
Geometric Coefficient of Variation 34.7
|
182.1 ng*hr/mL
Geometric Coefficient of Variation 53.2
|
127.6 ng*hr/mL
Geometric Coefficient of Variation 41.4
|
80.78 ng*hr/mL
Geometric Coefficient of Variation 39.6
|
61.32 ng*hr/mL
Geometric Coefficient of Variation 52.1
|
5.912 ng*hr/mL
Geometric Coefficient of Variation 31.6
|
119.6 ng*hr/mL
Geometric Coefficient of Variation 22.4
|
160.5 ng*hr/mL
Geometric Coefficient of Variation 42.8
|
388.6 ng*hr/mL
Geometric Coefficient of Variation 43.3
|
214.3 ng*hr/mL
Geometric Coefficient of Variation 36.5
|
386.8 ng*hr/mL
Geometric Coefficient of Variation 42.4
|
92.89 ng*hr/mL
Geometric Coefficient of Variation 37.9
|
169.5 ng*hr/mL
Geometric Coefficient of Variation 41.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II
M-II
|
3193.0 ng*hr/mL
Geometric Coefficient of Variation 68.0
|
5319.0 ng*hr/mL
Geometric Coefficient of Variation 56.3
|
4554.0 ng*hr/mL
Geometric Coefficient of Variation 41.2
|
1246.0 ng*hr/mL
Geometric Coefficient of Variation 46.0
|
2302.0 ng*hr/mL
Geometric Coefficient of Variation 57.0
|
392.0 ng*hr/mL
Geometric Coefficient of Variation 24.3
|
3039.0 ng*hr/mL
Geometric Coefficient of Variation 52.9
|
4470.0 ng*hr/mL
Geometric Coefficient of Variation 59.3
|
4352.0 ng*hr/mL
Geometric Coefficient of Variation 71.2
|
6030.0 ng*hr/mL
Geometric Coefficient of Variation 54.0
|
15430.0 ng*hr/mL
Geometric Coefficient of Variation 26.7
|
4683.0 ng*hr/mL
Geometric Coefficient of Variation 34.9
|
6836.0 ng*hr/mL
Geometric Coefficient of Variation 17.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dosePopulation: PK analysis set included all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.
Outcome measures
| Measure |
Cohort 4a-2: TAK-792 500 mg
n=5 Participants
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 2a: TAK-792 100 mg
n=6 Participants
TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 3a: TAK-792 250 mg
n=6 Participants
TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 1a-6a: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=5 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-1: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-2: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1 - 6b: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-1: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 6b: TAK-792 1250 mg
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: Placebo
TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: TAK-792 500 mg
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: Placebo
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II
TAK-792F
|
57.85 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 48.7
|
136.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 40.8
|
88.44 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 19.8
|
59.17 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 29.7
|
85.12 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 21.1
|
8.916 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 24.2
|
113.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 62.9
|
140.6 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 52.6
|
267.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 51.8
|
97.62 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 59.3
|
96.99 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 47.0
|
72.22 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 38.2
|
86.20 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 40.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II
M-I
|
8.401 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 34.5
|
21.92 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 49.3
|
14.65 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 31.7
|
13.40 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 21.5
|
8.786 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 29.9
|
1.707 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 30.8
|
14.0 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 17.1
|
17.13 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 42.6
|
37.54 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 51.4
|
21.73 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 34.7
|
25.15 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 28.8
|
12.86 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 24.5
|
20.04 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 34.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II
M-II
|
150.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 27.1
|
218.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 60.3
|
134.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 33.4
|
87.07 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 57.9
|
110.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 70.4
|
27.36 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 58.9
|
105.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 19.1
|
187.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 24.0
|
213.6 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 60.6
|
193.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 25.4
|
307.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 10.5
|
186.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 42.0
|
352.3 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 39.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dosePopulation: PK analysis set included all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.
Outcome measures
| Measure |
Cohort 4a-2: TAK-792 500 mg
n=5 Participants
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 2a: TAK-792 100 mg
n=6 Participants
TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 3a: TAK-792 250 mg
n=6 Participants
TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 1a-6a: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=5 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-1: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-2: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1 - 6b: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-1: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 6b: TAK-792 1250 mg
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: Placebo
TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: TAK-792 500 mg
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: Placebo
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II
TAK-792F
|
3.0000 hours
Full Range 48.7 • Interval 1.0 to 4.0
|
3.5000 hours
Full Range 40.8 • Interval 3.0 to 4.0
|
3.0000 hours
Full Range 19.8 • Interval 3.0 to 6.0
|
2.5000 hours
Full Range 29.7 • Interval 1.5 to 4.0
|
2.5000 hours
Full Range 21.1 • Interval 1.5 to 4.0
|
1.7500 hours
Full Range 24.2 • Interval 1.5 to 4.0
|
2.0000 hours
Full Range 62.9 • Interval 1.5 to 4.0
|
4.0000 hours
Full Range 52.6 • Interval 3.0 to 4.0
|
4.0000 hours
Full Range 51.8 • Interval 3.0 to 6.0
|
4.0000 hours
Full Range 59.3 • Interval 3.0 to 4.0
|
3.5000 hours
Full Range 47.0 • Interval 2.0 to 4.0
|
3.0000 hours
Full Range 38.2 • Interval 1.5 to 8.0
|
3.5000 hours
Full Range 40.9 • Interval 2.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II
M-I
|
3.0000 hours
Full Range 34.5 • Interval 1.5 to 6.0
|
3.5000 hours
Full Range 49.3 • Interval 3.0 to 16.0
|
2.5000 hours
Full Range 31.7 • Interval 1.0 to 6.0
|
2.0000 hours
Full Range 21.5 • Interval 1.5 to 8.0
|
1.7500 hours
Full Range 29.9 • Interval 1.5 to 4.0
|
1.5000 hours
Full Range 30.8 • Interval 1.0 to 3.0
|
6.0000 hours
Full Range 17.1 • Interval 1.5 to 8.0
|
3.5000 hours
Full Range 42.6 • Interval 1.5 to 8.0
|
4.0000 hours
Full Range 51.4 • Interval 3.0 to 8.0
|
5.0000 hours
Full Range 34.7 • Interval 1.0 to 8.0
|
6.0000 hours
Full Range 28.8 • Interval 2.0 to 10.0
|
4.0000 hours
Full Range 24.5 • Interval 2.0 to 8.0
|
5.0000 hours
Full Range 34.3 • Interval 3.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II
M-II
|
24.0000 hours
Full Range 27.1 • Interval 10.0 to 24.0
|
16.0000 hours
Full Range 60.3 • Interval 16.0 to 24.0
|
24.0000 hours
Full Range 33.4 • Interval 12.0 to 24.0
|
11.0000 hours
Full Range 57.9 • Interval 8.0 to 24.0
|
14.0000 hours
Full Range 70.4 • Interval 10.0 to 24.0
|
9.0000 hours
Full Range 58.9 • Interval 6.0 to 12.0
|
16.0000 hours
Full Range 19.1 • Interval 12.0 to 24.0
|
30.0000 hours
Full Range 24.0 • Interval 8.0 to 48.0
|
24.0000 hours
Full Range 60.6 • Interval 24.0 to 48.0
|
20.0000 hours
Full Range 25.4 • Interval 16.0 to 36.0
|
42.0000 hours
Full Range 10.5 • Interval 24.0 to 48.0
|
16.0000 hours
Full Range 42.0 • Interval 10.0 to 24.0
|
16.0000 hours
Full Range 39.8 • Interval 10.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: pre-dose and at multiple timepoints (6, 12, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dosePopulation: PK analysis set included all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.
Outcome measures
| Measure |
Cohort 4a-2: TAK-792 500 mg
n=5 Participants
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 2a: TAK-792 100 mg
n=6 Participants
TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 3a: TAK-792 250 mg
n=6 Participants
TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 1a-6a: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=5 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-1: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-2: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1 - 6b: Placebo
n=6 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-1: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 6b: TAK-792 1250 mg
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: Placebo
TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: TAK-792 500 mg
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: Placebo
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose
TAK-792F
|
0.2500 percentage (%) of dose
Standard Deviation 0.12329 • Interval 1.0 to 4.0
|
0.4484 percentage (%) of dose
Standard Deviation 0.19575 • Interval 3.0 to 4.0
|
0.3955 percentage (%) of dose
Standard Deviation 0.10436 • Interval 3.0 to 6.0
|
1.0367 percentage (%) of dose
Standard Deviation 0.18525 • Interval 1.5 to 4.0
|
0.6143 percentage (%) of dose
Standard Deviation 0.19055 • Interval 1.5 to 4.0
|
0.4903 percentage (%) of dose
Standard Deviation 0.12275 • Interval 1.5 to 4.0
|
0.5128 percentage (%) of dose
Standard Deviation 0.13384 • Interval 1.5 to 4.0
|
0.4733 percentage (%) of dose
Standard Deviation 0.21291 • Interval 3.0 to 4.0
|
0.5477 percentage (%) of dose
Standard Deviation 0.24886 • Interval 3.0 to 6.0
|
0.2830 percentage (%) of dose
Standard Deviation 0.16074 • Interval 3.0 to 4.0
|
0.1715 percentage (%) of dose
Standard Deviation 0.07766 • Interval 2.0 to 4.0
|
0.2755 percentage (%) of dose
Standard Deviation 0.08876 • Interval 1.5 to 8.0
|
0.2870 percentage (%) of dose
Standard Deviation 0.14673 • Interval 2.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose
M-II
|
20.0120 percentage (%) of dose
Standard Deviation 12.08593 • Interval 10.0 to 24.0
|
24.9333 percentage (%) of dose
Standard Deviation 13.03927 • Interval 16.0 to 24.0
|
31.8350 percentage (%) of dose
Standard Deviation 17.55999 • Interval 12.0 to 24.0
|
25.4567 percentage (%) of dose
Standard Deviation 14.21242 • Interval 8.0 to 24.0
|
35.1333 percentage (%) of dose
Standard Deviation 18.44361 • Interval 10.0 to 24.0
|
52.2833 percentage (%) of dose
Standard Deviation 9.37452 • Interval 6.0 to 12.0
|
21.9300 percentage (%) of dose
Standard Deviation 12.94284 • Interval 12.0 to 24.0
|
18.1750 percentage (%) of dose
Standard Deviation 7.30395 • Interval 8.0 to 48.0
|
15.2100 percentage (%) of dose
Standard Deviation 11.38256 • Interval 24.0 to 48.0
|
24.4667 percentage (%) of dose
Standard Deviation 13.80343 • Interval 16.0 to 36.0
|
39.4167 percentage (%) of dose
Standard Deviation 9.21421 • Interval 24.0 to 48.0
|
22.5383 percentage (%) of dose
Standard Deviation 15.47892 • Interval 10.0 to 24.0
|
26.7167 percentage (%) of dose
Standard Deviation 8.29516 • Interval 10.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose
M-I
|
0.6604 percentage (%) of dose
Standard Deviation 0.24546 • Interval 1.5 to 6.0
|
1.0155 percentage (%) of dose
Standard Deviation 0.62088 • Interval 3.0 to 16.0
|
1.3317 percentage (%) of dose
Standard Deviation 0.85211 • Interval 1.0 to 6.0
|
1.9150 percentage (%) of dose
Standard Deviation 0.72213 • Interval 1.5 to 8.0
|
1.8183 percentage (%) of dose
Standard Deviation 1.03695 • Interval 1.5 to 4.0
|
1.5667 percentage (%) of dose
Standard Deviation 0.35517 • Interval 1.0 to 3.0
|
1.4910 percentage (%) of dose
Standard Deviation 0.62949 • Interval 1.5 to 8.0
|
0.9552 percentage (%) of dose
Standard Deviation 0.56474 • Interval 1.5 to 8.0
|
1.2642 percentage (%) of dose
Standard Deviation 0.51113 • Interval 3.0 to 8.0
|
1.1630 percentage (%) of dose
Standard Deviation 0.25033 • Interval 1.0 to 8.0
|
1.1442 percentage (%) of dose
Standard Deviation 0.31888 • Interval 2.0 to 10.0
|
0.6330 percentage (%) of dose
Standard Deviation 0.32789 • Interval 2.0 to 8.0
|
0.7723 percentage (%) of dose
Standard Deviation 0.24873 • Interval 3.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -1: pre-dose and Day 1 (2.5 hours post dose)Population: Safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Cohort 4a-2: TAK-792 500 mg
n=2 Participants
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1: TAK-792 500 mg
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 2a: TAK-792 100 mg
n=5 Participants
TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 3a: TAK-792 250 mg
n=2 Participants
TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 1a-6a: Placebo
n=2 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=2 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-1: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-2: Placebo
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1 - 6b: Placebo
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-1: TAK-792 500 mg
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-1: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 6b: TAK-792 1250 mg
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: Placebo
TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: TAK-792 500 mg
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: Placebo
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2
Day 1: Total BCAA
|
2354.00 micromole*hour per liter (mcmol*hr/L)
Standard Deviation 433.174
|
1665.75 micromole*hour per liter (mcmol*hr/L)
Standard Deviation 119.524
|
—
|
1272.66 micromole*hour per liter (mcmol*hr/L)
Standard Deviation 84.565
|
1305.40 micromole*hour per liter (mcmol*hr/L)
Standard Deviation 172.393
|
1329.80 micromole*hour per liter (mcmol*hr/L)
Standard Deviation 64.912
|
1072.87 micromole*hour per liter (mcmol*hr/L)
Standard Deviation 178.282
|
2307.80 micromole*hour per liter (mcmol*hr/L)
Standard Deviation 568.514
|
1685.08 micromole*hour per liter (mcmol*hr/L)
Standard Deviation 163.129
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2
Day-1: Total BCAA
|
2011.75 micromole*hour per liter (mcmol*hr/L)
Standard Deviation 357.018
|
1982.10 micromole*hour per liter (mcmol*hr/L)
Standard Deviation 149.745
|
—
|
1372.16 micromole*hour per liter (mcmol*hr/L)
Standard Deviation 62.857
|
1125.05 micromole*hour per liter (mcmol*hr/L)
Standard Deviation 90.156
|
1257.10 micromole*hour per liter (mcmol*hr/L)
Standard Deviation 111.299
|
1102.43 micromole*hour per liter (mcmol*hr/L)
Standard Deviation 243.948
|
1879.40 micromole*hour per liter (mcmol*hr/L)
Standard Deviation 534.007
|
2124.73 micromole*hour per liter (mcmol*hr/L)
Standard Deviation 181.829
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -1: pre-dose and Day 1 at multiple time points (0.5, 1, 1.5, 2, 2.5, 4, 5, 6, 10, 11, 12, 24 hours; up to 24 hours) post-dosePopulation: Safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Cohort 4a-2: TAK-792 500 mg
n=2 Participants
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1: TAK-792 500 mg
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 2a: TAK-792 100 mg
n=5 Participants
TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 3a: TAK-792 250 mg
n=2 Participants
TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 1a-6a: Placebo
n=2 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=2 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-1: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-2: Placebo
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1 - 6b: Placebo
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-1: TAK-792 500 mg
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-1: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 6b: TAK-792 1250 mg
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: Placebo
TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: TAK-792 500 mg
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: Placebo
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2
Day-1: Total BCAA
|
1027.25 micromole per liter (mcmol/L)
Standard Deviation 301.157
|
1072.32 micromole per liter (mcmol/L)
Standard Deviation 112.642
|
—
|
630.64 micromole per liter (mcmol/L)
Standard Deviation 21.031
|
483.00 micromole per liter (mcmol/L)
Standard Deviation 47.235
|
603.85 micromole per liter (mcmol/L)
Standard Deviation 18.031
|
488.78 micromole per liter (mcmol/L)
Standard Deviation 112.097
|
938.00 micromole per liter (mcmol/L)
Standard Deviation 239.285
|
1161.05 micromole per liter (mcmol/L)
Standard Deviation 173.252
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2
Day 1: Total BCAA
|
1227.65 micromole per liter (mcmol/L)
Standard Deviation 212.627
|
760.93 micromole per liter (mcmol/L)
Standard Deviation 48.105
|
—
|
605.88 micromole per liter (mcmol/L)
Standard Deviation 60.406
|
593.25 micromole per liter (mcmol/L)
Standard Deviation 80.681
|
604.90 micromole per liter (mcmol/L)
Standard Deviation 34.365
|
507.08 micromole per liter (mcmol/L)
Standard Deviation 85.660
|
1227.00 micromole per liter (mcmol/L)
Standard Deviation 386.222
|
800.78 micromole per liter (mcmol/L)
Standard Deviation 132.421
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -1: pre-dose and Day 1 at multiple time points (0.5, 1, 1.5, 2, 2.5, 4, 5, 6, 10, 11, 12, 24 hours; up to 24 hours) post-dosePopulation: Safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Cohort 4a-2: TAK-792 500 mg
n=2 Participants
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1: TAK-792 500 mg
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 2a: TAK-792 100 mg
n=5 Participants
TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 3a: TAK-792 250 mg
n=2 Participants
TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 1a-6a: Placebo
n=2 Participants
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=6 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=2 Participants
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-1: TAK-792 750 mg
n=6 Participants
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-2: Placebo
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1 - 6b: Placebo
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-1: TAK-792 500 mg
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-1: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 6b: TAK-792 1250 mg
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: Placebo
TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: TAK-792 500 mg
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: Placebo
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: TAK-792 750 mg
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2
Day-1: Total BCAA
|
1.25 hour
Interval 1.0 to 1.5
|
1.00 hour
Interval 1.0 to 1.5
|
—
|
1.00 hour
Interval 0.5 to 1.5
|
1.75 hour
Interval 1.0 to 2.5
|
1.00 hour
Interval 1.0 to 1.0
|
0.75 hour
Interval 0.0 to 2.5
|
1.00 hour
Interval 1.0 to 1.0
|
1.00 hour
Interval 0.5 to 1.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2
Day 1: Total BCAA
|
1.00 hour
Interval 1.0 to 1.0
|
1.00 hour
Interval 0.5 to 2.0
|
—
|
1.00 hour
Interval 0.5 to 1.0
|
1.75 hour
Interval 1.5 to 2.0
|
1.00 hour
Interval 1.0 to 1.0
|
0.75 hour
Interval 0.5 to 1.0
|
1.00 hour
Interval 1.0 to 1.0
|
1.25 hour
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1a-6a: Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 1a: TAK-792 30 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2a: TAK-792 100 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3a: TAK-792 250 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4a-1: TAK-792 500 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 5a-1: TAK-792 750 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 6a: TAK-792 1250 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 4a-2: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 4a-2: TAK-792 500 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 5a-2: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 5a-2: TAK-792 750 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 4b-1 - 6b: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4b-1: TAK-792 500 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 5b-1: TAK-792 750 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 6b: TAK-792 1250 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4b-2: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4b-2: TAK-792 500 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 5b-2: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 5b-2: TAK-792 750 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 |
Cohort 1a-6a: Placebo
n=12 participants at risk
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 1a: TAK-792 30 mg
n=6 participants at risk
TAK-792 30 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 2a: TAK-792 100 mg
n=6 participants at risk
TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 3a: TAK-792 250 mg
n=6 participants at risk
TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4a-1: TAK-792 500 mg
n=6 participants at risk
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 5a-1: TAK-792 750 mg
n=6 participants at risk
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants.
|
Cohort 6a: TAK-792 1250 mg
n=6 participants at risk
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4a-2: Placebo
n=2 participants at risk
TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4a-2: TAK-792 500 mg
n=5 participants at risk
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: Placebo
n=2 participants at risk
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 5a-2: TAK-792 750 mg
n=6 participants at risk
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants.
|
Cohort 4b-1 - 6b: Placebo
n=6 participants at risk
TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-1: TAK-792 500 mg
n=6 participants at risk
TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-1: TAK-792 750 mg
n=6 participants at risk
TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 6b: TAK-792 1250 mg
n=6 participants at risk
TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: Placebo
n=2 participants at risk
TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 4b-2: TAK-792 500 mg
n=6 participants at risk
TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: Placebo
n=2 participants at risk
TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
Cohort 5b-2: TAK-792 750 mg
n=6 participants at risk
TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Occult blood positive
|
16.7%
2/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood glucose increased
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood urine present
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Protein urine present
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
White blood cell count increased
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No publication related to study results will be made without Sponsor's prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER