Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-137 in Healthy Participants (NCT NCT02334982)
NCT ID: NCT02334982
Last Updated: 2015-02-10
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. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
47 participants
Primary outcome timeframe
Day 1 to 14 days after the last dose of study medication(Up to 30 days)
Results posted on
2015-02-10
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 21 June 2013 to 30 January 2014.
Healthy Volunteers were enrolled in a 6 Cohort randomized, dose escalating study at doses of 0.5, 2,5, 10 and 20 mg TAK-137 tablets or placebo single dose once in Cohorts 5,1,2,3 and 6 fasting respectively. Cohort 4 received 5 mg tablets or placebo single dose fasting then 5 mg or placebo fed.
Participant milestones
| Measure |
Cohort 1: TAK-137 2 mg
TAK-137 2 mg, tablets, orally, once on Day 1.
|
Cohort 2: TAK-137 5 mg
TAK-137 5 mg, tablets, orally, once on Day 1.
|
Cohort 3: TAK-137 10 mg
TAK-137 10 mg, tablets, orally, once on Day 1.
|
Cohort 4: TAK-137 5 mg Food Effect
TAK-137 5 mg, tablets, orally, under fasted conditions, once on Day 1 of Period 1, followed by 14 days of follow-up, followed by TAK-137 5 mg, tablets, orally, under fed conditions, once on Day 1 of Period 2.
|
Cohort 5: TAK-137 0.5 mg
TAK-137 0.5 mg, tablets, orally, once on Day 1.
|
Cohort 6: TAK-137 20 mg
TAK-137 20 mg, tablets, orally, once on Day 1.
|
Cohorts 1-6: Placebo
TAK-137 placebo-matching tablets, orally, once on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
6
|
6
|
6
|
6
|
12
|
|
Overall Study
COMPLETED
|
6
|
5
|
6
|
6
|
6
|
6
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-137 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Cohort 1: TAK-137 2 mg
n=6 Participants
TAK-137 2 mg, tablets, orally, once on Day 1.
|
Cohort 2: TAK-137 5 mg
n=5 Participants
TAK-137 5 mg, tablets, orally, once on Day 1.
|
Cohort 3: TAK-137 10 mg
n=6 Participants
TAK-137 10 mg, tablets, orally, once on Day 1.
|
Cohort 4: TAK-137 5 mg Food Effect
n=6 Participants
TAK-137 5 mg, tablets, orally, under fasted conditions, once on Day 1 of Period 1, followed by 14 days of follow-up, followed by TAK-137 5 mg, tablets, orally, under fed conditions, once on Day 1 of Period 2.
|
Cohort 5: TAK-137 0.5 mg
n=6 Participants
TAK-137 0.5 mg, tablets, orally, once on Day 1.
|
Cohort 6: TAK-137 20 mg
n=6 Participants
TAK-137 20 mg, tablets, orally, once on Day 1.
|
Cohorts 1-6: Placebo
n=12 Participants
TAK-137 placebo-matching tablets, orally, once on Day 1.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
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
|
1 participants
n=24 Participants
|
|
Age, Continuous
|
34.8 years
STANDARD_DEVIATION 9.00 • n=5 Participants
|
34.0 years
STANDARD_DEVIATION 8.66 • n=7 Participants
|
40.5 years
STANDARD_DEVIATION 8.22 • n=5 Participants
|
36.5 years
STANDARD_DEVIATION 9.27 • n=4 Participants
|
24.7 years
STANDARD_DEVIATION 3.88 • n=21 Participants
|
38.5 years
STANDARD_DEVIATION 10.63 • n=8 Participants
|
31.5 years
STANDARD_DEVIATION 6.87 • n=8 Participants
|
34.9 years
STANDARD_DEVIATION 9.43 • n=24 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
20 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
27 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
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
|
0 participants
n=8 Participants
|
2 participants
n=8 Participants
|
4 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=8 Participants
|
5 participants
n=8 Participants
|
19 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
2 participants
n=21 Participants
|
3 participants
n=8 Participants
|
5 participants
n=8 Participants
|
22 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 participants
n=5 Participants
|
1 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
|
1 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
1 participants
n=8 Participants
|
3 participants
n=8 Participants
|
15 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic or Latino
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
5 participants
n=4 Participants
|
3 participants
n=21 Participants
|
5 participants
n=8 Participants
|
9 participants
n=8 Participants
|
32 participants
n=24 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=8 Participants
|
12 participants
n=8 Participants
|
47 participants
n=24 Participants
|
|
Height
|
170.3 cm
STANDARD_DEVIATION 8.19 • n=5 Participants
|
173.2 cm
STANDARD_DEVIATION 13.22 • n=7 Participants
|
178.0 cm
STANDARD_DEVIATION 6.63 • n=5 Participants
|
172.3 cm
STANDARD_DEVIATION 8.62 • n=4 Participants
|
171.5 cm
STANDARD_DEVIATION 6.44 • n=21 Participants
|
164.7 cm
STANDARD_DEVIATION 11.74 • n=8 Participants
|
166.2 cm
STANDARD_DEVIATION 9.44 • n=8 Participants
|
171.6 cm
STANDARD_DEVIATION 9.52 • n=24 Participants
|
|
Weight
|
70.97 kg
STANDARD_DEVIATION 15.299 • n=5 Participants
|
79.86 kg
STANDARD_DEVIATION 14.870 • n=7 Participants
|
81.88 kg
STANDARD_DEVIATION 15.381 • n=5 Participants
|
74.40 kg
STANDARD_DEVIATION 18.840 • n=4 Participants
|
75.05 kg
STANDARD_DEVIATION 12.228 • n=21 Participants
|
64.18 kg
STANDARD_DEVIATION 14.297 • n=8 Participants
|
73.23 kg
STANDARD_DEVIATION 9.378 • n=8 Participants
|
74.23 kg
STANDARD_DEVIATION 15.306 • n=24 Participants
|
|
Body Mass Index (BMI)
|
24.22 kg/m^2
STANDARD_DEVIATION 3.276 • n=5 Participants
|
26.48 kg/m^2
STANDARD_DEVIATION 2.138 • n=7 Participants
|
25.68 kg/m^2
STANDARD_DEVIATION 3.323 • n=5 Participants
|
24.68 kg/m^2
STANDARD_DEVIATION 4.260 • n=4 Participants
|
25.38 kg/m^2
STANDARD_DEVIATION 2.905 • n=21 Participants
|
23.38 kg/m^2
STANDARD_DEVIATION 2.315 • n=8 Participants
|
26.51 kg/m^2
STANDARD_DEVIATION 2.658 • n=8 Participants
|
24.93 kg/m^2
STANDARD_DEVIATION 3.074 • n=24 Participants
|
|
Caffeine Consumption
Yes
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=8 Participants
|
5 participants
n=8 Participants
|
12 participants
n=24 Participants
|
|
Caffeine Consumption
No
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
5 participants
n=21 Participants
|
5 participants
n=8 Participants
|
7 participants
n=8 Participants
|
35 participants
n=24 Participants
|
|
Smoking Classification
Never smoked
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
5 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=8 Participants
|
12 participants
n=8 Participants
|
46 participants
n=24 Participants
|
|
Smoking Classification
Ex-smoker
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 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
|
|
Alcohol Classification
Never
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=8 Participants
|
12 participants
n=8 Participants
|
44 participants
n=24 Participants
|
|
Alcohol Classification
Current
|
0 participants
n=5 Participants
|
0 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
|
3 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Day 1 to 14 days after the last dose of study medication(Up to 30 days)Population: Safety population included all participants who received at least one dose of study medication. 8 of the 47 enrolled participants participated in Cohort 4 fed.
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. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
TAK-137 0.5 mg
n=6 Participants
TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 2 mg
n=6 Participants
TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 5 mg (Fasting)
n=11 Participants
TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 10 mg
n=6 Participants
TAK-137 10 mg, tablets, orally, once on Day 1.
|
TAK-137 20 mg
n=6 Participants
TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 Placebo
n=12 Participants
TAK-137 placebo-matching tablets, orally, once on Day 1.
|
TAK-137 5 mg (Fed)
n=6 Participants
TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
|
Placebo (Fed)
n=2 Participants
TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
50.0 percentage of participants
|
33.3 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 to 14 days after the last dose of study medication (Up to 30 Days)Population: Participants from the Safety population, all participants who received at least one dose of study medication, with data available for analysis. 8 of the 47 enrolled participants participated in Cohort 4 fed.
The percentage of participants with any markedly abnormal standard safety laboratory values was collected throughout study.
Outcome measures
| Measure |
TAK-137 0.5 mg
n=6 Participants
TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 2 mg
n=6 Participants
TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 5 mg (Fasting)
n=11 Participants
TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 10 mg
n=6 Participants
TAK-137 10 mg, tablets, orally, once on Day 1.
|
TAK-137 20 mg
n=6 Participants
TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 Placebo
n=12 Participants
TAK-137 placebo-matching tablets, orally, once on Day 1.
|
TAK-137 5 mg (Fed)
n=6 Participants
TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
|
Placebo (Fed)
n=2 Participants
TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Abnormal Safety Laboratory Findings
|
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 to 14 days after the last dose of study medicationPopulation: Participants from the Safety population, all participants who received at least one dose of study medication, with data available for analysis. 8 of the 47 enrolled participants participated in Cohort 4 fed.
The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study.
Outcome measures
| Measure |
TAK-137 0.5 mg
n=6 Participants
TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 2 mg
n=6 Participants
TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 5 mg (Fasting)
n=11 Participants
TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 10 mg
n=6 Participants
TAK-137 10 mg, tablets, orally, once on Day 1.
|
TAK-137 20 mg
n=6 Participants
TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 Placebo
n=12 Participants
TAK-137 placebo-matching tablets, orally, once on Day 1.
|
TAK-137 5 mg (Fed)
n=6 Participants
TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
|
Placebo (Fed)
n=2 Participants
TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Systolic BP (3 min after standing) >180 mmHG
|
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
|
|
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Pulse (5 min after supine) <50 bpm
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Pulse (5 min after supine) >120 bpm
|
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
|
|
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Pulse (1 min after standing) <50 bpm
|
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
|
|
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Pulse (1 min after standing) >120 bpm
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
8.3 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Pulse (3 min after standing) <50 bpm
|
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
|
|
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Pulse (3 min after standing) >120 bpm
|
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
|
16.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Systolic BP (5 min after supine) <85 mmHG
|
0 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 With Markedly Abnormal Vital Sign Measurements
Systolic BP (5 min after supine) >180 mmHG
|
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
|
|
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Systolic BP (1 min after standing) <85 mmHG
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Systolic BP (1 min after standing) >180 mmHG
|
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
|
|
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Systolic BP (3 min after standing) <85 mmHG
|
0 percentage of participants
|
16.7 percentage of participants
|
9.1 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Diastolic BP (5 min after supine) <50 mmHg
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Diastolic BP (5 min after supine) >110 mmHg
|
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
|
|
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Diastolic BP (1 min after standing) <50 mmHg
|
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
|
0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Diastolic BP (1 min after standing) >110 mmHg
|
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
|
|
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Diastolic BP (3 min after standing) <50 mmHg
|
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
|
|
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Diastolic BP (3 min after standing) >110 mmHg
|
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
|
SECONDARY outcome
Timeframe: Day 1Population: Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Outcome measures
| Measure |
TAK-137 0.5 mg
n=6 Participants
TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 2 mg
n=5 Participants
TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 5 mg (Fasting)
n=6 Participants
TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 10 mg
n=6 Participants
TAK-137 10 mg, tablets, orally, once on Day 1.
|
TAK-137 20 mg
n=6 Participants
TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 Placebo
n=6 Participants
TAK-137 placebo-matching tablets, orally, once on Day 1.
|
TAK-137 5 mg (Fed)
n=6 Participants
TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
|
Placebo (Fed)
TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-137
|
38.8 ng/mL
Standard Deviation 8.64
|
68.90 ng/mL
Standard Deviation 7.40
|
121.1 ng/mL
Standard Deviation 28.44
|
61.1 ng/mL
Standard Deviation 16.11
|
9.0 ng/mL
Standard Deviation 0.76
|
206.1 ng/mL
Standard Deviation 80.72
|
85.9 ng/mL
Standard Deviation 28.58
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.
Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Outcome measures
| Measure |
TAK-137 0.5 mg
n=6 Participants
TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 2 mg
n=5 Participants
TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 5 mg (Fasting)
n=6 Participants
TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 10 mg
n=6 Participants
TAK-137 10 mg, tablets, orally, once on Day 1.
|
TAK-137 20 mg
n=6 Participants
TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 Placebo
n=6 Participants
TAK-137 placebo-matching tablets, orally, once on Day 1.
|
TAK-137 5 mg (Fed)
n=6 Participants
TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
|
Placebo (Fed)
TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137
|
2.00 hours
Interval 1.0 to 3.0
|
3.00 hours
Interval 1.5 to 6.0
|
3.00 hours
Interval 2.0 to 8.0
|
2.50 hours
Interval 1.0 to 3.0
|
2.00 hours
Interval 1.0 to 3.0
|
2.50 hours
Interval 1.5 to 6.0
|
5.50 hours
Interval 2.0 to 12.0
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.
(AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).
Outcome measures
| Measure |
TAK-137 0.5 mg
n=6 Participants
TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 2 mg
n=5 Participants
TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 5 mg (Fasting)
n=6 Participants
TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 10 mg
n=6 Participants
TAK-137 10 mg, tablets, orally, once on Day 1.
|
TAK-137 20 mg
n=6 Participants
TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 Placebo
n=6 Participants
TAK-137 placebo-matching tablets, orally, once on Day 1.
|
TAK-137 5 mg (Fed)
n=6 Participants
TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
|
Placebo (Fed)
TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-137
|
405 ng*hr/mL
Standard Deviation 121.6
|
1668 ng*hr/mL
Standard Deviation 787.6
|
3012 ng*hr/mL
Standard Deviation 2204.1
|
1191 ng*hr/mL
Standard Deviation 767.9
|
94 ng*hr/mL
Standard Deviation 41.9
|
5346 ng*hr/mL
Standard Deviation 3292.4
|
1470 ng*hr/mL
Standard Deviation 434.5
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.
AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Outcome measures
| Measure |
TAK-137 0.5 mg
n=6 Participants
TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 2 mg
n=5 Participants
TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 5 mg (Fasting)
n=6 Participants
TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 10 mg
n=6 Participants
TAK-137 10 mg, tablets, orally, once on Day 1.
|
TAK-137 20 mg
n=6 Participants
TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 Placebo
n=6 Participants
TAK-137 placebo-matching tablets, orally, once on Day 1.
|
TAK-137 5 mg (Fed)
n=6 Participants
TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
|
Placebo (Fed)
TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-137
|
408 ng*hr/mL
Standard Deviation 121.64
|
1696 ng*hr/mL
Standard Deviation 803.9
|
3135 ng*hr/mL
Standard Deviation 2380.8
|
1198 ng*hr/mL
Standard Deviation 766.64
|
97 ng*hr/mL
Standard Deviation 43.24
|
5353 ng*hr/mL
Standard Deviation 3295.2
|
1474 ng*hr/mL
Standard Deviation 436.1
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.
Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Outcome measures
| Measure |
TAK-137 0.5 mg
n=6 Participants
TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 2 mg
n=5 Participants
TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 5 mg (Fasting)
n=6 Participants
TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 10 mg
n=6 Participants
TAK-137 10 mg, tablets, orally, once on Day 1.
|
TAK-137 20 mg
n=6 Participants
TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 Placebo
n=6 Participants
TAK-137 placebo-matching tablets, orally, once on Day 1.
|
TAK-137 5 mg (Fed)
n=6 Participants
TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
|
Placebo (Fed)
TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-life (T1/2) for TAK-137_101
|
6.65 hours
Standard Deviation 2.462
|
12.66 hours
Standard Deviation 2.491
|
13.60 hours
Standard Deviation 7.105
|
15.77 hours
Standard Deviation 10.553
|
8.54 hours
Standard Deviation 4.487
|
13.09 hours
Standard Deviation 5.276
|
10.52 hours
Standard Deviation 3.875
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.
CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-inf), expressed in liters per hour (L/hr).
Outcome measures
| Measure |
TAK-137 0.5 mg
n=6 Participants
TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 2 mg
n=5 Participants
TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 5 mg (Fasting)
n=6 Participants
TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 10 mg
n=6 Participants
TAK-137 10 mg, tablets, orally, once on Day 1.
|
TAK-137 20 mg
n=6 Participants
TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 Placebo
n=6 Participants
TAK-137 placebo-matching tablets, orally, once on Day 1.
|
TAK-137 5 mg (Fed)
n=6 Participants
TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
|
Placebo (Fed)
TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) for TAK-137_101
|
5.22 liters/hour
Standard Deviation 1.304
|
3.66 liters/hour
Standard Deviation 1.912
|
5.23 liters/hour
Standard Deviation 3.877
|
5.91 liters/hour
Standard Deviation 3.372
|
6.26 liters/hour
Standard Deviation 3.062
|
7.19 liters/hour
Standard Deviation 6.976
|
3.63 liters/hour
Standard Deviation 0.996
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.
Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by λz.
Outcome measures
| Measure |
TAK-137 0.5 mg
n=6 Participants
TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 2 mg
n=5 Participants
TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 5 mg (Fasting)
n=6 Participants
TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 10 mg
n=6 Participants
TAK-137 10 mg, tablets, orally, once on Day 1.
|
TAK-137 20 mg
n=6 Participants
TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 Placebo
n=6 Participants
TAK-137 placebo-matching tablets, orally, once on Day 1.
|
TAK-137 5 mg (Fed)
n=6 Participants
TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
|
Placebo (Fed)
TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) for TAK-137_101
|
48.57 liters
Standard Deviation 15.521
|
62.26 liters
Standard Deviation 23.596
|
81.23 liters
Standard Deviation 47.499
|
134.49 liters
Standard Deviation 150.393
|
62.85 liters
Standard Deviation 14.652
|
110.48 liters
Standard Deviation 86.222
|
52.97 liters
Standard Deviation 17.267
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.
Total amount of drug excreted in urine from time 0 to time t, calculated as Sum (Cu\*Vu), where Cu is the concentration of drug excreted in urine and Vu is the volume of urine excreted.
Outcome measures
| Measure |
TAK-137 0.5 mg
n=6 Participants
TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 2 mg
n=5 Participants
TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 5 mg (Fasting)
n=6 Participants
TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 10 mg
n=6 Participants
TAK-137 10 mg, tablets, orally, once on Day 1.
|
TAK-137 20 mg
n=6 Participants
TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 Placebo
n=6 Participants
TAK-137 placebo-matching tablets, orally, once on Day 1.
|
TAK-137 5 mg (Fed)
n=6 Participants
TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
|
Placebo (Fed)
TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Total Amount of Drug (TAK-137) Excreted in Urine From Time 0 to Time t (Ae[0-t])
|
0.0039 mg
Standard Deviation 0.00161
|
0.0164 mg
Standard Deviation 0.01492
|
0.0470 mg
Standard Deviation 0.04281
|
0.0192 mg
Standard Deviation 0.01465
|
0.0002 mg
Standard Deviation 0.00034
|
0.0585 mg
Standard Deviation 0.04417
|
0.0217 mg
Standard Deviation 0.01335
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.
Fraction of drug excreted in urine, calculated as Fe=(Ae\[0-t\]/dose)×100.
Outcome measures
| Measure |
TAK-137 0.5 mg
n=6 Participants
TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 2 mg
n=5 Participants
TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 5 mg (Fasting)
n=6 Participants
TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 10 mg
n=6 Participants
TAK-137 10 mg, tablets, orally, once on Day 1.
|
TAK-137 20 mg
n=6 Participants
TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 Placebo
n=6 Participants
TAK-137 placebo-matching tablets, orally, once on Day 1.
|
TAK-137 5 mg (Fed)
n=6 Participants
TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
|
Placebo (Fed)
TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Fraction of TAK-137 Excreted in Urine (Fe)
|
0.19 percent excreted
Standard Deviation 0.080
|
0.33 percent excreted
Standard Deviation 0.298
|
0.47 percent excreted
Standard Deviation 0.428
|
0.38 percent excreted
Standard Deviation 0.293
|
0.04 percent excreted
Standard Deviation 0.068
|
0.29 percent excreted
Standard Deviation 0.221
|
0.43 percent excreted
Standard Deviation 0.267
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.
CLr is a measure of apparent clearance of the drug from the urine, calculated as CLr=Ae(0-t)/AUC(0-96).
Outcome measures
| Measure |
TAK-137 0.5 mg
n=6 Participants
TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 2 mg
n=5 Participants
TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 5 mg (Fasting)
n=6 Participants
TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 10 mg
n=6 Participants
TAK-137 10 mg, tablets, orally, once on Day 1.
|
TAK-137 20 mg
n=6 Participants
TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 Placebo
n=6 Participants
TAK-137 placebo-matching tablets, orally, once on Day 1.
|
TAK-137 5 mg (Fed)
n=6 Participants
TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
|
Placebo (Fed)
TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Renal Clearance (CLr) for TAK-137
|
0.0093 liters/hour
Standard Deviation 0.00268
|
0.0094 liters/hour
Standard Deviation 0.00577
|
0.0138 liters/hour
Standard Deviation 0.00477
|
0.0164 liters/hour
Standard Deviation 0.00626
|
0.0031 liters/hour
Standard Deviation 0.00500
|
0.0117 liters/hour
Standard Deviation 0.00453
|
0.0150 liters/hour
Standard Deviation 0.00804
|
—
|
Adverse Events
TAK-137 0.5 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TAK-137 2 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
TAK-137 5 mg (Fasting)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TAK-137 10 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
TAK-137 20 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Fasting
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
TAK-137 5 mg (Fed)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo (Fed)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TAK-137 0.5 mg
n=6 participants at risk
TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 2 mg
n=6 participants at risk
TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 5 mg (Fasting)
n=11 participants at risk
TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
|
TAK-137 10 mg
n=6 participants at risk
TAK-137 10 mg, tablets, orally, once on Day 1.
|
TAK-137 20 mg
n=6 participants at risk
TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
|
Placebo Fasting
n=12 participants at risk
TAK-137 placebo-matching tablets, orally, fasting, once on Day 1.
|
TAK-137 5 mg (Fed)
n=6 participants at risk
TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
|
Placebo (Fed)
n=2 participants at risk
TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and 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 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and 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 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and 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 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Orthostatic heart rate response increased
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and 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 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and 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 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and 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 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and 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 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and 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 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/11 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Day 1 to 14 days after the last dose of study medication (Up to 30 days).
At each visit the investigator had to document any occurrence of adverse events and 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