Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Participants (NCT NCT02706834)
NCT ID: NCT02706834
Last Updated: 2018-10-19
Results Overview
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Day 1 up to 30 days after last dose of study drug (up to 85 days)
Results posted on
2018-10-19
Participant Flow
Participants took part in the study at 2 investigative sites in the United States from 01 March 2016 to 17 June 2016.
Non-Japanese healthy participants were randomized to Cohort 1 or Cohort 2 with 4 different sequences to receive TAK-828 or placebo in a ratio of 9:3. Japanese healthy participants were randomized into Cohort 3 with 3 different sequences to receive TAK-828 or placebo in a ratio of 8:4.
Participant milestones
| Measure |
Cohort 1, Sequence I
Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 1, Sequence II
Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 1, Sequence III
Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 1, Sequence IV
Non-Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 2, Sequence I
Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 2, Sequence II
Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 2, Sequence III
Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 2, Sequence IV
Non-Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. There was a 7-day washout period between each period. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 3, Sequence I
Japanese participants. TAK-828 15 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 3, Sequence II
Japanese participants. TAK-828 15 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 150 mg, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 3, Sequence III
Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 150 mg, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
1
|
2
|
2
|
3
|
2
|
3
|
3
|
3
|
4
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1, Sequence I
Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 1, Sequence II
Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 1, Sequence III
Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 1, Sequence IV
Non-Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 2, Sequence I
Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 2, Sequence II
Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 2, Sequence III
Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 2, Sequence IV
Non-Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. There was a 7-day washout period between each period. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 3, Sequence I
Japanese participants. TAK-828 15 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 3, Sequence II
Japanese participants. TAK-828 15 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 150 mg, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 3, Sequence III
Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 150 mg, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Pretreatment Event/Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Voluntary Withdrawal
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Other Reason Not Specified
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Cohort 1, Sequence I
n=3 Participants
Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 1, Sequence II
n=3 Participants
Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 1, Sequence III
n=3 Participants
Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 1, Sequence IV
n=3 Participants
Non-Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 2, Sequence I
n=3 Participants
Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 2, Sequence II
n=3 Participants
Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 2, Sequence III
n=3 Participants
Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 2, Sequence IV
n=3 Participants
Non-Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. There was a 7-day washout period between each period. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 3, Sequence I
n=4 Participants
Japanese participants. TAK-828 15 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 3, Sequence II
n=4 Participants
Japanese participants. TAK-828 15 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 150 mg, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.
|
Cohort 3, Sequence III
n=4 Participants
Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 150 mg, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.3 years
STANDARD_DEVIATION 10.26 • n=5 Participants
|
29.3 years
STANDARD_DEVIATION 11.68 • n=7 Participants
|
34.7 years
STANDARD_DEVIATION 4.16 • n=5 Participants
|
36.7 years
STANDARD_DEVIATION 9.71 • n=4 Participants
|
28.0 years
STANDARD_DEVIATION 6.24 • n=21 Participants
|
40.3 years
STANDARD_DEVIATION 8.39 • n=8 Participants
|
32.3 years
STANDARD_DEVIATION 10.69 • n=8 Participants
|
40.7 years
STANDARD_DEVIATION 5.51 • n=24 Participants
|
37.5 years
STANDARD_DEVIATION 10.02 • n=42 Participants
|
34.3 years
STANDARD_DEVIATION 6.65 • n=42 Participants
|
43.8 years
STANDARD_DEVIATION 5.44 • n=42 Participants
|
35.9 years
STANDARD_DEVIATION 8.45 • 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
|
1 Participants
n=21 Participants
|
1 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
|
2 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
34 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
2 participants
n=8 Participants
|
0 participants
n=8 Participants
|
1 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
5 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
2 participants
n=21 Participants
|
1 participants
n=8 Participants
|
3 participants
n=8 Participants
|
2 participants
n=24 Participants
|
4 participants
n=42 Participants
|
4 participants
n=42 Participants
|
4 participants
n=42 Participants
|
31 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
4 participants
n=42 Participants
|
4 participants
n=42 Participants
|
4 participants
n=42 Participants
|
13 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
1 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
6 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
3 participants
n=8 Participants
|
3 participants
n=8 Participants
|
2 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
17 participants
n=42 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=8 Participants
|
3 participants
n=8 Participants
|
3 participants
n=24 Participants
|
4 participants
n=42 Participants
|
4 participants
n=42 Participants
|
4 participants
n=42 Participants
|
36 participants
n=42 Participants
|
|
Height
|
176.3 cm
STANDARD_DEVIATION 3.21 • n=5 Participants
|
176.3 cm
STANDARD_DEVIATION 2.89 • n=7 Participants
|
173.3 cm
STANDARD_DEVIATION 5.69 • n=5 Participants
|
176.7 cm
STANDARD_DEVIATION 1.53 • n=4 Participants
|
169.7 cm
STANDARD_DEVIATION 12.50 • n=21 Participants
|
166.1 cm
STANDARD_DEVIATION 9.54 • n=8 Participants
|
178.0 cm
STANDARD_DEVIATION 4.36 • n=8 Participants
|
170.3 cm
STANDARD_DEVIATION 7.23 • n=24 Participants
|
174.3 cm
STANDARD_DEVIATION 6.24 • n=42 Participants
|
168.5 cm
STANDARD_DEVIATION 5.00 • n=42 Participants
|
173.0 cm
STANDARD_DEVIATION 8.64 • n=42 Participants
|
172.9 cm
STANDARD_DEVIATION 6.82 • n=42 Participants
|
|
Weight
|
81.87 kg
STANDARD_DEVIATION 8.686 • n=5 Participants
|
85.23 kg
STANDARD_DEVIATION 2.686 • n=7 Participants
|
78.60 kg
STANDARD_DEVIATION 9.569 • n=5 Participants
|
83.23 kg
STANDARD_DEVIATION 9.160 • n=4 Participants
|
75.53 kg
STANDARD_DEVIATION 8.173 • n=21 Participants
|
66.87 kg
STANDARD_DEVIATION 8.135 • n=8 Participants
|
81.63 kg
STANDARD_DEVIATION 11.946 • n=8 Participants
|
77.13 kg
STANDARD_DEVIATION 16.354 • n=24 Participants
|
66.73 kg
STANDARD_DEVIATION 1.563 • n=42 Participants
|
65.18 kg
STANDARD_DEVIATION 3.149 • n=42 Participants
|
69.88 kg
STANDARD_DEVIATION 10.806 • n=42 Participants
|
74.93 kg
STANDARD_DEVIATION 10.416 • n=42 Participants
|
|
Body Mass Index (BMI)
|
26.28 kg/m^2
STANDARD_DEVIATION 1.828 • n=5 Participants
|
27.41 kg/m^2
STANDARD_DEVIATION 0.755 • n=7 Participants
|
26.08 kg/m^2
STANDARD_DEVIATION 1.765 • n=5 Participants
|
26.65 kg/m^2
STANDARD_DEVIATION 2.727 • n=4 Participants
|
26.34 kg/m^2
STANDARD_DEVIATION 3.071 • n=21 Participants
|
24.25 kg/m^2
STANDARD_DEVIATION 1.772 • n=8 Participants
|
25.73 kg/m^2
STANDARD_DEVIATION 3.170 • n=8 Participants
|
26.37 kg/m^2
STANDARD_DEVIATION 3.709 • n=24 Participants
|
22.05 kg/m^2
STANDARD_DEVIATION 1.864 • n=42 Participants
|
22.96 kg/m^2
STANDARD_DEVIATION 0.527 • n=42 Participants
|
23.20 kg/m^2
STANDARD_DEVIATION 1.622 • n=42 Participants
|
25.01 kg/m^2
STANDARD_DEVIATION 2.584 • n=42 Participants
|
|
Smoking Classification
Never Smoked
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=8 Participants
|
3 participants
n=8 Participants
|
3 participants
n=24 Participants
|
3 participants
n=42 Participants
|
4 participants
n=42 Participants
|
3 participants
n=42 Participants
|
33 participants
n=42 Participants
|
|
Smoking Classification
Current Smoker
|
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
|
|
Smoking Classification
Ex-smoker
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 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
|
3 participants
n=42 Participants
|
|
Alcohol Classification
Never Drunk
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=8 Participants
|
1 participants
n=8 Participants
|
3 participants
n=24 Participants
|
2 participants
n=42 Participants
|
3 participants
n=42 Participants
|
1 participants
n=42 Participants
|
16 participants
n=42 Participants
|
|
Alcohol Classification
Current Drinker
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
1 participants
n=8 Participants
|
0 participants
n=24 Participants
|
2 participants
n=42 Participants
|
0 participants
n=42 Participants
|
2 participants
n=42 Participants
|
11 participants
n=42 Participants
|
|
Alcohol Classification
Ex-drinker
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
1 participants
n=8 Participants
|
1 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
1 participants
n=42 Participants
|
8 participants
n=42 Participants
|
|
Alcohol Classification
Missing
|
1 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
|
1 participants
n=42 Participants
|
|
Xanthine/Caffeine Consumption
Yes
|
3 participants
n=5 Participants
|
2 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
|
1 participants
n=24 Participants
|
3 participants
n=42 Participants
|
2 participants
n=42 Participants
|
4 participants
n=42 Participants
|
25 participants
n=42 Participants
|
|
Xanthine/Caffeine Consumption
No
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=8 Participants
|
1 participants
n=8 Participants
|
2 participants
n=24 Participants
|
1 participants
n=42 Participants
|
2 participants
n=42 Participants
|
0 participants
n=42 Participants
|
11 participants
n=42 Participants
|
|
Female Reproductive Status
Postmenopausal
|
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
|
1 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
|
1 participants
n=42 Participants
|
|
Female Reproductive Status
Surgically Sterile
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 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
|
1 participants
n=42 Participants
|
|
Female Reproductive Status
Female of Childbearing Potential
|
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
|
|
Female Reproductive Status
N/A (Participant is Male)
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=8 Participants
|
3 participants
n=8 Participants
|
3 participants
n=24 Participants
|
4 participants
n=42 Participants
|
4 participants
n=42 Participants
|
4 participants
n=42 Participants
|
34 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 30 days after last dose of study drug (up to 85 days)Population: Safety Set included all participants who received at least 1 dose of study drug.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Cohort 2: TAK-828 50 mg/ Fasted
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 2: TAK-828 200 mg/ Fasted
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 150 mg/ Fasted in Japanese Participants
n=9 Participants
Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 0.1 mg/ Fasted in Non-Japanese Participants
n=10 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
TAK-828 0.5 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 2: TAK-828 100 mg/ Fed
n=4 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
Cohort 3: Placebo
n=12 Participants
Japanese participants in Cohort 3 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2 or 3.
|
Cohort 3: TAK-828 15 mg/ Fasted
n=8 Participants
Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
Cohort 3: TAK-828 100 mg/ Fasted
n=8 Participants
Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 3: TAK-828 150 mg/ Fasted
n=6 Participants
Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 3 mg/ Fasted in Non-Japanese Participants
n=8 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
TAK-828 15 mg/ Fasted in Non-Japanese Participants
n=7 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 50 mg/ Fasted in Non-Japanese Participants
n=7 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
TAK-828 100 mg/ Fasted in Non-Japanese Participants
n=8 Participants
Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.
|
TAK-828 100 mg/ Fed in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
TAK-828 200 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event (TEAE)
|
11.1 percentage of participants
|
11.1 percentage of participants
|
22.2 percentage of participants
|
30.0 percentage of participants
|
55.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
75.0 percentage of participants
|
66.7 percentage of participants
|
37.5 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 up to 30 days after last dose of study drug (up to 85 days)Population: Safety Set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Cohort 2: TAK-828 50 mg/ Fasted
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 2: TAK-828 200 mg/ Fasted
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 150 mg/ Fasted in Japanese Participants
n=9 Participants
Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 0.1 mg/ Fasted in Non-Japanese Participants
n=10 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
TAK-828 0.5 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 2: TAK-828 100 mg/ Fed
n=4 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
Cohort 3: Placebo
n=12 Participants
Japanese participants in Cohort 3 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2 or 3.
|
Cohort 3: TAK-828 15 mg/ Fasted
n=8 Participants
Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
Cohort 3: TAK-828 100 mg/ Fasted
n=8 Participants
Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 3: TAK-828 150 mg/ Fasted
n=6 Participants
Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 3 mg/ Fasted in Non-Japanese Participants
n=8 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
TAK-828 15 mg/ Fasted in Non-Japanese Participants
n=7 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 50 mg/ Fasted in Non-Japanese Participants
n=7 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
TAK-828 100 mg/ Fasted in Non-Japanese Participants
n=8 Participants
Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.
|
TAK-828 100 mg/ Fed in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
TAK-828 200 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 up to 7 days after last dose of study drug (up to 52 days)Population: Safety Set included all participants who received at least 1 dose of study drug.
Hematology and Chemistry values that met the following criteria were considered to be markedly abnormal: Erythrocytes, Hematocrit and Hemoglobin \<0.8\*Lower Limit of Normal (LLN) or \>1.2\*Upper Limit of Normal ULN.; Leukocytes \<0.5\*LLN or \>1.5\*ULN; Platelet \<75 or \>600 10\^9/liter (L). Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase \>3\*ULN; Albumin \<25 g/L; Bilirubin \> 34.2 umol/L; Blood Urea Nitrogen \>10.7 mmol/L; Chloride \<75 or \>126 mmol/L; Creatinine \>177 umol/L; Direct Bilirubin \>2\*ULN; Glucose \<2.8 or \>19.4 mmol/L; Potassium \<3.0 or \>6.0 mmol/L; Protein \<0.8\*LLN or \>1.2\*ULN; Sodium \<130 or \>150 mmol/L.
Outcome measures
| Measure |
Cohort 2: TAK-828 50 mg/ Fasted
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 2: TAK-828 200 mg/ Fasted
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 150 mg/ Fasted in Japanese Participants
n=9 Participants
Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 0.1 mg/ Fasted in Non-Japanese Participants
n=10 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
TAK-828 0.5 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 2: TAK-828 100 mg/ Fed
n=4 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
Cohort 3: Placebo
n=12 Participants
Japanese participants in Cohort 3 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2 or 3.
|
Cohort 3: TAK-828 15 mg/ Fasted
n=8 Participants
Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
Cohort 3: TAK-828 100 mg/ Fasted
n=8 Participants
Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 3: TAK-828 150 mg/ Fasted
n=6 Participants
Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 3 mg/ Fasted in Non-Japanese Participants
n=8 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
TAK-828 15 mg/ Fasted in Non-Japanese Participants
n=7 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 50 mg/ Fasted in Non-Japanese Participants
n=7 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
TAK-828 100 mg/ Fasted in Non-Japanese Participants
n=8 Participants
Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.
|
TAK-828 100 mg/ Fed in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
TAK-828 200 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 up to 7 days after last dose of study drug (up to 52 days)Population: Safety Set included all participants who received at least 1 dose of study drug.
Vital signs measurements that met the following criteria were considered to be markedly abnormal: Systolic Blood Pressure (SBP) \<85 mmHg or \>180 mmHg supine laying face upward) or standing; Diastolic Blood Pressure (DBP) \<50 mmHg or \>110 mmHg supine or standing; Pulse Rate (PR) \<50 beats/minute (bpm) or \>120 bpm supine or standing; Temperature \<35.6 degrees Celsius (C) or \>37.7 degrees C.
Outcome measures
| Measure |
Cohort 2: TAK-828 50 mg/ Fasted
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 2: TAK-828 200 mg/ Fasted
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 150 mg/ Fasted in Japanese Participants
n=9 Participants
Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 0.1 mg/ Fasted in Non-Japanese Participants
n=10 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
TAK-828 0.5 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 2: TAK-828 100 mg/ Fed
n=4 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
Cohort 3: Placebo
n=12 Participants
Japanese participants in Cohort 3 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2 or 3.
|
Cohort 3: TAK-828 15 mg/ Fasted
n=8 Participants
Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
Cohort 3: TAK-828 100 mg/ Fasted
n=8 Participants
Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 3: TAK-828 150 mg/ Fasted
n=6 Participants
Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 3 mg/ Fasted in Non-Japanese Participants
n=8 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
TAK-828 15 mg/ Fasted in Non-Japanese Participants
n=7 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 50 mg/ Fasted in Non-Japanese Participants
n=7 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
TAK-828 100 mg/ Fasted in Non-Japanese Participants
n=8 Participants
Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.
|
TAK-828 100 mg/ Fed in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
TAK-828 200 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
SBP <85 mmHg: standing, after 3 minutes
|
11.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
DBP <50 mmHg: supine, after 5 minutes
|
11.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
DBP <50 mmHg: standing, after 3 minutes
|
11.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
10.0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
PR >120 bpm: standing, after 1 minute
|
0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
28.6 percentage of participants
|
12.5 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
PR <50 bpm: standing, after 3 minutes
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
PR >120 bpm: standing, after 3 minutes
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
Temperature: <35.6 C
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
10.0 percentage of participants
|
22.2 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
12.5 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
SBP <85 mmHg: standing, after 1 minute
|
0 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
PR <50 bpm: supine, after 5 minutes
|
22.2 percentage of participants
|
22.2 percentage of participants
|
22.2 percentage of participants
|
20.0 percentage of participants
|
22.2 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
25.0 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
33.3 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
PR <50 bpm: standing, after 1 minute
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 up to 7 days after last dose of study drug (up to 52 days)Population: Safety Set included all participants who received at least 1 dose of study drug.
Heart Rate \<50 beats per minute (bpm) \>120 bpm; QTcB (Bazett's Correction Formula) ≤50 milliseconds (msec) or ≥500 msec OR ≥30 msec change from Baseline and ≥450 msec; QTcF (Fridericia's Correction Formula) ≤50 msec or ≥500 msec OR ≥30 msec change from Baseline (CFB) and ≥450 msec.
Outcome measures
| Measure |
Cohort 2: TAK-828 50 mg/ Fasted
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 2: TAK-828 200 mg/ Fasted
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 150 mg/ Fasted in Japanese Participants
n=9 Participants
Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 0.1 mg/ Fasted in Non-Japanese Participants
n=10 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
TAK-828 0.5 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 2: TAK-828 100 mg/ Fed
n=4 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
Cohort 3: Placebo
n=12 Participants
Japanese participants in Cohort 3 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2 or 3.
|
Cohort 3: TAK-828 15 mg/ Fasted
n=8 Participants
Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
Cohort 3: TAK-828 100 mg/ Fasted
n=8 Participants
Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 3: TAK-828 150 mg/ Fasted
n=6 Participants
Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 3 mg/ Fasted in Non-Japanese Participants
n=8 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
TAK-828 15 mg/ Fasted in Non-Japanese Participants
n=7 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 50 mg/ Fasted in Non-Japanese Participants
n=7 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
TAK-828 100 mg/ Fasted in Non-Japanese Participants
n=8 Participants
Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.
|
TAK-828 100 mg/ Fed in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
TAK-828 200 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Measurements at Least Once Post-dose
Heart Rate <50 bpm
|
33.3 percentage of participants
|
33.3 percentage of participants
|
55.6 percentage of participants
|
20.0 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
8.3 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
28.6 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
44.4 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Measurements at Least Once Post-dose
QTcB: ≥500 msec OR ≥30 msec CFB and ≥450 msec
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dosePopulation: Pharmacokinetic (PK) Set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma or urine concentration of TAK-828F. Food effect statistical analysis is based on 10 participants who received TAK-828 100 mg under fasted and fed conditions.
Outcome measures
| Measure |
Cohort 2: TAK-828 50 mg/ Fasted
n=8 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 2: TAK-828 200 mg/ Fasted
n=8 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 150 mg/ Fasted in Japanese Participants
n=6 Participants
Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 0.1 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
TAK-828 0.5 mg/ Fasted in Non-Japanese Participants
n=8 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 2: TAK-828 100 mg/ Fed
Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
Cohort 3: Placebo
Japanese participants in Cohort 3 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2 or 3.
|
Cohort 3: TAK-828 15 mg/ Fasted
Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
Cohort 3: TAK-828 100 mg/ Fasted
Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 3: TAK-828 150 mg/ Fasted
Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 3 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
TAK-828 15 mg/ Fasted in Non-Japanese Participants
n=7 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 50 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
TAK-828 100 mg/ Fasted in Non-Japanese Participants
n=16 Participants
Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.
|
TAK-828 100 mg/ Fed in Non-Japanese Participants
n=12 Participants
Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
TAK-828 200 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-828F (Free Base of TAK-828)
|
1400 ng/mL
Standard Deviation 114
|
9530 ng/mL
Standard Deviation 1030
|
14300 ng/mL
Standard Deviation 2470
|
5.96 ng/mL
Standard Deviation 0.982
|
38.6 ng/mL
Standard Deviation 3.56
|
—
|
—
|
—
|
—
|
—
|
247 ng/mL
Standard Deviation 28.7
|
1150 ng/mL
Standard Deviation 201
|
4820 ng/mL
Standard Deviation 1090
|
8900 ng/mL
Standard Deviation 1870
|
3730 ng/mL
Standard Deviation 850
|
18400 ng/mL
Standard Deviation 2950
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dosePopulation: Pharmacokinetic (PK) Set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma or urine concentration of TAK-828F.
Outcome measures
| Measure |
Cohort 2: TAK-828 50 mg/ Fasted
n=8 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 2: TAK-828 200 mg/ Fasted
n=8 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 150 mg/ Fasted in Japanese Participants
n=6 Participants
Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 0.1 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
TAK-828 0.5 mg/ Fasted in Non-Japanese Participants
n=8 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 2: TAK-828 100 mg/ Fed
Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
Cohort 3: Placebo
Japanese participants in Cohort 3 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2 or 3.
|
Cohort 3: TAK-828 15 mg/ Fasted
Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
Cohort 3: TAK-828 100 mg/ Fasted
Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 3: TAK-828 150 mg/ Fasted
Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 3 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
TAK-828 15 mg/ Fasted in Non-Japanese Participants
n=7 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 50 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
TAK-828 100 mg/ Fasted in Non-Japanese Participants
n=16 Participants
Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.
|
TAK-828 100 mg/ Fed in Non-Japanese Participants
n=12 Participants
Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
TAK-828 200 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax: Time of First Occurrence of Cmax for TAK-828F (Free Base of TAK-828)
|
1.00 hours (h)
Interval 0.5 to 2.0
|
1.00 hours (h)
Interval 0.5 to 1.5
|
1.00 hours (h)
Interval 0.5 to 1.03
|
1.00 hours (h)
Interval 0.5 to 1.13
|
1.00 hours (h)
Interval 0.517 to 2.0
|
—
|
—
|
—
|
—
|
—
|
1.00 hours (h)
Interval 0.5 to 1.0
|
1.00 hours (h)
Interval 1.0 to 1.5
|
1.00 hours (h)
Interval 0.5 to 1.5
|
1.00 hours (h)
Interval 0.5 to 1.02
|
3.50 hours (h)
Interval 1.0 to 4.0
|
1.00 hours (h)
Interval 0.5 to 1.0
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dosePopulation: Pharmacokinetic (PK) Set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma or urine concentration of TAK-828F. T1/2z was not calculated for the TAK-828 0.1 mg arm because Lambda z, required for the calculation, was not calculated due to the lack of a well-defined terminal elimination phase.
Outcome measures
| Measure |
Cohort 2: TAK-828 50 mg/ Fasted
n=8 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 2: TAK-828 200 mg/ Fasted
n=8 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 150 mg/ Fasted in Japanese Participants
n=6 Participants
Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 0.1 mg/ Fasted in Non-Japanese Participants
Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
TAK-828 0.5 mg/ Fasted in Non-Japanese Participants
n=7 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 2: TAK-828 100 mg/ Fed
Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
Cohort 3: Placebo
Japanese participants in Cohort 3 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2 or 3.
|
Cohort 3: TAK-828 15 mg/ Fasted
Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
Cohort 3: TAK-828 100 mg/ Fasted
Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 3: TAK-828 150 mg/ Fasted
Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 3 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
TAK-828 15 mg/ Fasted in Non-Japanese Participants
n=7 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 50 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
TAK-828 100 mg/ Fasted in Non-Japanese Participants
n=16 Participants
Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.
|
TAK-828 100 mg/ Fed in Non-Japanese Participants
n=12 Participants
Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
TAK-828 200 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
t1/2z: Terminal Disposition Phase Half-Life for TAK-828F (Free Base of TAK-828)
|
6.71 h
Standard Deviation 1.37
|
6.71 h
Standard Deviation 0.950
|
6.44 h
Standard Deviation 0.406
|
—
|
5.38 h
Standard Deviation 0.568
|
—
|
—
|
—
|
—
|
—
|
4.94 h
Standard Deviation 1.11
|
6.53 h
Standard Deviation 1.14
|
7.51 h
Standard Deviation 1.95
|
7.53 h
Standard Deviation 1.32
|
7.04 h
Standard Deviation 0.701
|
7.97 h
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dosePopulation: PK Set included participants who received at least 1 dose of study drug and had at least 1 measurable plasma or urine concentration of TAK-828F.Food effect statistical analysis is based on 10 participants who received TAK-828 100 mg fasted and fed.AUC∞ was not calculated for TAK-828 0.1 mg arm due to lack of well-defined terminal elimination phase.
Outcome measures
| Measure |
Cohort 2: TAK-828 50 mg/ Fasted
n=8 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 2: TAK-828 200 mg/ Fasted
n=8 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 150 mg/ Fasted in Japanese Participants
n=6 Participants
Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 0.1 mg/ Fasted in Non-Japanese Participants
Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
TAK-828 0.5 mg/ Fasted in Non-Japanese Participants
n=7 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 2: TAK-828 100 mg/ Fed
Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
Cohort 3: Placebo
Japanese participants in Cohort 3 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2 or 3.
|
Cohort 3: TAK-828 15 mg/ Fasted
Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
Cohort 3: TAK-828 100 mg/ Fasted
Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 3: TAK-828 150 mg/ Fasted
Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 3 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
TAK-828 15 mg/ Fasted in Non-Japanese Participants
n=7 Participants
Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
TAK-828 50 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
TAK-828 100 mg/ Fasted in Non-Japanese Participants
n=16 Participants
Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.
|
TAK-828 100 mg/ Fed in Non-Japanese Participants
n=12 Participants
Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
TAK-828 200 mg/ Fasted in Non-Japanese Participants
n=9 Participants
Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-828F (Free Base of TAK-828)
|
8560 ng*h/mL
Standard Deviation 1610
|
54600 ng*h/mL
Standard Deviation 13400
|
83700 ng*h/mL
Standard Deviation 16400
|
—
|
214 ng*h/mL
Standard Deviation 30.4
|
—
|
—
|
—
|
—
|
—
|
1150 ng*h/mL
Standard Deviation 211
|
5930 ng*h/mL
Standard Deviation 1430
|
23100 ng*h/mL
Standard Deviation 5400
|
45400 ng*h/mL
Standard Deviation 10300
|
38000 ng*h/mL
Standard Deviation 7370
|
106000 ng*h/mL
Standard Deviation 20800
|
Adverse Events
Cohort 1: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1: TAK-828 0.1 mg/ Fasted
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 1: TAK-828 0.5 mg/ Fasted
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1: TAK-828 15 mg/ Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1: TAK-828 100 mg/ Fasted
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 1: TAK-828 100 mg/ Fed
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2: TAK-828 3 mg/ Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: TAK-828 50 mg/ Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: TAK-828 200 mg/ Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: TAK-828 100 mg/ Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2: TAK-828 100 mg/ Fed
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3: TAK-828 15 mg/ Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3: TAK-828 100 mg/ Fasted
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 3: TAK-828 150 mg/ Fasted
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Placebo
n=10 participants at risk
Non-Japanese participants in Cohort 1 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2, 3 or 4.
|
Cohort 1: TAK-828 0.1 mg/ Fasted
n=9 participants at risk
Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
Cohort 1: TAK-828 0.5 mg/ Fasted
n=8 participants at risk
Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 1: TAK-828 15 mg/ Fasted
n=7 participants at risk
Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
Cohort 1: TAK-828 100 mg/ Fasted
n=7 participants at risk
Non-Japanese participants in Cohort 1 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.
|
Cohort 1: TAK-828 100 mg/ Fed
n=8 participants at risk
Non-Japanese participants in Cohort 1 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
Cohort 2: Placebo
n=9 participants at risk
Non-Japanese participants in Cohort 2 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2, 3 or 4.
|
Cohort 2: TAK-828 3 mg/ Fasted
n=9 participants at risk
Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
Cohort 2: TAK-828 50 mg/ Fasted
n=9 participants at risk
Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 2: TAK-828 200 mg/ Fasted
n=9 participants at risk
Cohort 2: TAK-828 200 mg/ Fasted Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
Cohort 2: TAK-828 100 mg/ Fasted
n=9 participants at risk
Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.
|
Cohort 2: TAK-828 100 mg/ Fed
n=4 participants at risk
Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
Cohort 3: Placebo
n=12 participants at risk
Japanese participants in Cohort 3 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2 or 3.
|
Cohort 3: TAK-828 15 mg/ Fasted
n=8 participants at risk
Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
Cohort 3: TAK-828 100 mg/ Fasted
n=8 participants at risk
Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 3: TAK-828 150 mg/ Fasted
n=6 participants at risk
Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Cohort 1: Placebo
n=10 participants at risk
Non-Japanese participants in Cohort 1 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2, 3 or 4.
|
Cohort 1: TAK-828 0.1 mg/ Fasted
n=9 participants at risk
Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
Cohort 1: TAK-828 0.5 mg/ Fasted
n=8 participants at risk
Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 1: TAK-828 15 mg/ Fasted
n=7 participants at risk
Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
Cohort 1: TAK-828 100 mg/ Fasted
n=7 participants at risk
Non-Japanese participants in Cohort 1 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.
|
Cohort 1: TAK-828 100 mg/ Fed
n=8 participants at risk
Non-Japanese participants in Cohort 1 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
Cohort 2: Placebo
n=9 participants at risk
Non-Japanese participants in Cohort 2 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2, 3 or 4.
|
Cohort 2: TAK-828 3 mg/ Fasted
n=9 participants at risk
Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
Cohort 2: TAK-828 50 mg/ Fasted
n=9 participants at risk
Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 2: TAK-828 200 mg/ Fasted
n=9 participants at risk
Cohort 2: TAK-828 200 mg/ Fasted Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
Cohort 2: TAK-828 100 mg/ Fasted
n=9 participants at risk
Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.
|
Cohort 2: TAK-828 100 mg/ Fed
n=4 participants at risk
Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.
|
Cohort 3: Placebo
n=12 participants at risk
Japanese participants in Cohort 3 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2 or 3.
|
Cohort 3: TAK-828 15 mg/ Fasted
n=8 participants at risk
Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.
|
Cohort 3: TAK-828 100 mg/ Fasted
n=8 participants at risk
Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.
|
Cohort 3: TAK-828 150 mg/ Fasted
n=6 participants at risk
Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
3/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
22.2%
2/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and 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
Constipation
|
0.00%
0/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and 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
Nausea
|
10.0%
1/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Feeling abnormal
|
0.00%
0/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and 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
Musculoskeletal discomfort
|
0.00%
0/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and 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
Temporomandibular joint syndrome
|
0.00%
0/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
22.2%
2/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and 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
Presyncope
|
0.00%
0/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Chromaturia
|
10.0%
1/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
10.0%
1/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and 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 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Foreign body reaction
|
0.00%
0/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and 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 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/10 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From Day 1 up to 30 days after last dose of study drug (up to 85 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER