Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of TAK-137 in Adults With Attention-Deficit/Hyperactivity Disorder. (NCT NCT02163915)
NCT ID: NCT02163915
Last Updated: 2016-07-11
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 (example, 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 (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
47 participants
Primary outcome timeframe
Day 1 up to Day 14
Results posted on
2016-07-11
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 23 May 2014 to 03 November 2014.
Participants with a historical diagnosis of attention-deficit/hyperactivity disorder (ADHD) were enrolled in one of the five cohorts to receive TAK-137 (0.5 milligram \[mg\], 2 mg, 5 mg, 10 mg, or matching placebo) once daily for up to 7 days.
Participant milestones
| Measure |
Cohorts 1-4: Placebo
TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
|
Cohort 1: TAK-137 0.5 mg
TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 2: TAK-137 2 mg
TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 3: TAK-137 5 mg
TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 4: TAK-137 10 mg
TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
10
|
9
|
10
|
|
Overall Study
COMPLETED
|
7
|
8
|
8
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
2
|
3
|
4
|
Reasons for withdrawal
| Measure |
Cohorts 1-4: Placebo
TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
|
Cohort 1: TAK-137 0.5 mg
TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 2: TAK-137 2 mg
TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 3: TAK-137 5 mg
TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 4: TAK-137 10 mg
TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
2
|
2
|
2
|
|
Overall Study
Study termination
|
1
|
0
|
0
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of TAK-137 in Adults With Attention-Deficit/Hyperactivity Disorder.
Baseline characteristics by cohort
| Measure |
Cohorts 1-4: Placebo
n=10 Participants
TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
|
Cohort 1: TAK-137 0.5 mg
n=8 Participants
TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 2: TAK-137 2 mg
n=10 Participants
TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 3: TAK-137 5 mg
n=9 Participants
TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 4: TAK-137 10 mg
n=10 Participants
TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
28.1 years
STANDARD_DEVIATION 10.59 • n=5 Participants
|
33.0 years
STANDARD_DEVIATION 9.65 • n=7 Participants
|
28.6 years
STANDARD_DEVIATION 8.75 • n=5 Participants
|
32.6 years
STANDARD_DEVIATION 10.73 • n=4 Participants
|
31.6 years
STANDARD_DEVIATION 11.68 • n=21 Participants
|
30.6 years
STANDARD_DEVIATION 10.10 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
4 participants
n=4 Participants
|
7 participants
n=21 Participants
|
24 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
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
|
1 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
3 participants
n=21 Participants
|
19 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
3 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
8 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic or Latino
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
7 participants
n=21 Participants
|
39 participants
n=8 Participants
|
|
Height
|
171.8 centimeter (cm)
STANDARD_DEVIATION 7.96 • n=5 Participants
|
172.4 centimeter (cm)
STANDARD_DEVIATION 9.07 • n=7 Participants
|
171.7 centimeter (cm)
STANDARD_DEVIATION 7.09 • n=5 Participants
|
174.8 centimeter (cm)
STANDARD_DEVIATION 7.36 • n=4 Participants
|
172.4 centimeter (cm)
STANDARD_DEVIATION 5.23 • n=21 Participants
|
172.6 centimeter (cm)
STANDARD_DEVIATION 7.13 • n=8 Participants
|
|
Weight
|
77.42 kilogram (kg)
STANDARD_DEVIATION 10.211 • n=5 Participants
|
76.01 kilogram (kg)
STANDARD_DEVIATION 14.537 • n=7 Participants
|
75.11 kilogram (kg)
STANDARD_DEVIATION 14.376 • n=5 Participants
|
79.61 kilogram (kg)
STANDARD_DEVIATION 9.205 • n=4 Participants
|
74.73 kilogram (kg)
STANDARD_DEVIATION 13.815 • n=21 Participants
|
76.54 kilogram (kg)
STANDARD_DEVIATION 12.777 • n=8 Participants
|
|
Body Mass Index
|
26.25 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.182 • n=5 Participants
|
25.46 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.408 • n=7 Participants
|
25.36 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.942 • n=5 Participants
|
26.02 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.204 • n=4 Participants
|
25.09 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.969 • n=21 Participants
|
25.64 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.303 • n=8 Participants
|
|
Caffeine Consumption
Had caffeine consumption
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
7 participants
n=4 Participants
|
4 participants
n=21 Participants
|
29 participants
n=8 Participants
|
|
Caffeine Consumption
Had no caffeine consumption
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
2 participants
n=4 Participants
|
6 participants
n=21 Participants
|
18 participants
n=8 Participants
|
|
Smoking Status
Never smoked
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
9 participants
n=21 Participants
|
40 participants
n=8 Participants
|
|
Smoking Status
Ex-smoker
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
7 participants
n=8 Participants
|
|
Alcohol consumption
Never drank
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
9 participants
n=21 Participants
|
27 participants
n=8 Participants
|
|
Alcohol consumption
Current drinker
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
1 participants
n=21 Participants
|
17 participants
n=8 Participants
|
|
Alcohol consumption
Ex-drinker
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
3 participants
n=8 Participants
|
|
Female Reproductive Status
Surgically sterile
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
3 participants
n=8 Participants
|
|
Female Reproductive Status
Female of childbearing potential
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
9 participants
n=8 Participants
|
|
Female Reproductive Status
Not applicable
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
7 participants
n=4 Participants
|
7 participants
n=21 Participants
|
35 participants
n=8 Participants
|
|
ADHD Category
Combined
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
9 participants
n=4 Participants
|
9 participants
n=21 Participants
|
43 participants
n=8 Participants
|
|
ADHD Category
Inattentive
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
4 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 14Population: Safety analysis set was defined as all participants who received at least one 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. An AE can therefore be any unfavorable and unintended sign (example, 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 (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Cohorts 1-4: Placebo
n=10 Participants
TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
|
Cohort 1: TAK-137 0.5 mg
n=8 Participants
TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 2: TAK-137 2 mg
n=10 Participants
TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 3: TAK-137 5 mg
n=9 Participants
TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 4: TAK-137 10 mg
n=10 Participants
TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
|
50.0 percentage of participants
|
62.5 percentage of participants
|
0 percentage of participants
|
66.7 percentage of participants
|
20.0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 8Population: Safety analysis set was defined as all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Cohorts 1-4: Placebo
n=10 Participants
TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
|
Cohort 1: TAK-137 0.5 mg
n=8 Participants
TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 2: TAK-137 2 mg
n=10 Participants
TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 3: TAK-137 5 mg
n=9 Participants
TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 4: TAK-137 10 mg
n=10 Participants
TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 8Population: Safety analysis set was defined as all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Cohorts 1-4: Placebo
n=10 Participants
TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
|
Cohort 1: TAK-137 0.5 mg
n=8 Participants
TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 2: TAK-137 2 mg
n=10 Participants
TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 3: TAK-137 5 mg
n=9 Participants
TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 4: TAK-137 10 mg
n=10 Participants
TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Pulse Measurements at Least Once Post Dose
Supine, After 5 Minutes: < 50 bpm
|
50 percentage of participants
|
37.5 percentage of participants
|
50 percentage of participants
|
22.2 percentage of participants
|
40 percentage of participants
|
|
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Pulse Measurements at Least Once Post Dose
Standing, After 1 Minute: < 50 bpm
|
10 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 Takeda Markedly Abnormal Criteria for Pulse Measurements at Least Once Post Dose
Standing, After 1 Minute: > 120 bpm
|
10 percentage of participants
|
0 percentage of participants
|
10 percentage of participants
|
0 percentage of participants
|
40 percentage of participants
|
|
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Pulse Measurements at Least Once Post Dose
Standing, After 3 Minutes: < 50 bpm
|
20 percentage of participants
|
12.5 percentage of participants
|
20 percentage of participants
|
22.2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Pulse Measurements at Least Once Post Dose
Standing, After 3 Minutes: > 120 bpm
|
30 percentage of participants
|
0 percentage of participants
|
10 percentage of participants
|
0 percentage of participants
|
50 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 8Population: Safety analysis set was defined as all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Cohorts 1-4: Placebo
n=10 Participants
TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
|
Cohort 1: TAK-137 0.5 mg
n=8 Participants
TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 2: TAK-137 2 mg
n=10 Participants
TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 3: TAK-137 5 mg
n=9 Participants
TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 4: TAK-137 10 mg
n=10 Participants
TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Blood Pressure Measurements at Least Once Post Dose
SBP: Standing, After 3 Minutes: <85 mmHg
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
10 percentage of participants
|
|
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Blood Pressure Measurements at Least Once Post Dose
DBP: Supine, After 5 Minutes: <50 mmHg
|
30 percentage of participants
|
25 percentage of participants
|
10 percentage of participants
|
44.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Blood Pressure Measurements at Least Once Post Dose
DBP: Standing, After 3 Minutes: <50 mmHg
|
30 percentage of participants
|
25 percentage of participants
|
30 percentage of participants
|
44.4 percentage of participants
|
20 percentage of participants
|
|
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Blood Pressure Measurements at Least Once Post Dose
DBP: Standing, After 3 Minutes: >110 mmHg
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
10 percentage of participants
|
|
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Blood Pressure Measurements at Least Once Post Dose
SBP: Supine, After 5 Minutes: < 85 mmHg
|
10 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
10 percentage of participants
|
|
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Blood Pressure Measurements at Least Once Post Dose
DBP: Standing, After 1 Minute: <50 mmHg
|
30 percentage of participants
|
0 percentage of participants
|
10 percentage of participants
|
22.2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Blood Pressure Measurements at Least Once Post Dose
DBP: Standing, After 1 Minute: >110 mmHg
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
10 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 8Population: Safety analysis set was defined as all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Cohorts 1-4: Placebo
n=10 Participants
TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
|
Cohort 1: TAK-137 0.5 mg
n=8 Participants
TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 2: TAK-137 2 mg
n=10 Participants
TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 3: TAK-137 5 mg
n=9 Participants
TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 4: TAK-137 10 mg
n=10 Participants
TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Heart Rate Measurements at Least Once Post Dose
|
30 percentage of participants
|
25 percentage of participants
|
30 percentage of participants
|
22.2 percentage of participants
|
30 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 8Population: Safety analysis set was defined as all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Cohorts 1-4: Placebo
n=10 Participants
TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
|
Cohort 1: TAK-137 0.5 mg
n=8 Participants
TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 2: TAK-137 2 mg
n=10 Participants
TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 3: TAK-137 5 mg
n=9 Participants
TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 4: TAK-137 10 mg
n=10 Participants
TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose
PR Interval: ≤80 msec
|
0 percentage of participants
|
0 percentage of participants
|
10 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose
PR Interval: ≥200 msec
|
0 percentage of participants
|
25 percentage of participants
|
30 percentage of participants
|
22.2 percentage of participants
|
10 percentage of participants
|
|
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose
QRS Interval: ≤80 msec
|
10 percentage of participants
|
0 percentage of participants
|
20 percentage of participants
|
22.2 percentage of participants
|
20 percentage of participants
|
|
Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose
QT Interval: ≥460 msec
|
0 percentage of participants
|
0 percentage of participants
|
10 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dosePopulation: Pharmacokinetic analysis set was defined as all participants who received at least one dose of study drug and had at least one measurable plasma concentration.
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 |
Cohorts 1-4: Placebo
n=8 Participants
TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
|
Cohort 1: TAK-137 0.5 mg
n=10 Participants
TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 2: TAK-137 2 mg
n=8 Participants
TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 3: TAK-137 5 mg
n=10 Participants
TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 4: TAK-137 10 mg
TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
|
|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-137
|
8.32 nanogram per milliliter (ng/mL)
Standard Deviation 2.651
|
28.04 nanogram per milliliter (ng/mL)
Standard Deviation 7.554
|
64.91 nanogram per milliliter (ng/mL)
Standard Deviation 24.592
|
103.13 nanogram per milliliter (ng/mL)
Standard Deviation 27.822
|
—
|
SECONDARY outcome
Timeframe: Day 7 pre-dose and at multiple timepoints (up to 24 hours) post-dosePopulation: Pharmacokinetic analysis set was defined as all participants who received at least one dose of study drug and had at least one measurable plasma concentration.
Maximum observed steady-state plasma concentration during a dosing interval.
Outcome measures
| Measure |
Cohorts 1-4: Placebo
n=8 Participants
TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
|
Cohort 1: TAK-137 0.5 mg
n=8 Participants
TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 2: TAK-137 2 mg
n=6 Participants
TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 3: TAK-137 5 mg
n=6 Participants
TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 4: TAK-137 10 mg
TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
|
|---|---|---|---|---|---|
|
Cmax, ss: Maximum Observed Plasma Concentration at Steady State for TAK-137
|
7.79 ng/mL
Standard Deviation 2.039
|
38.01 ng/mL
Standard Deviation 22.749
|
86.25 ng/mL
Standard Deviation 35.079
|
176.25 ng/mL
Standard Deviation 113.096
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 7 pre-dose and at multiple timepoints (up to 24 hours) post-dosePopulation: Pharmacokinetic analysis set was defined as all participants who received at least one dose of study drug and had at least one measurable plasma concentration.
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Outcome measures
| Measure |
Cohorts 1-4: Placebo
n=8 Participants
TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
|
Cohort 1: TAK-137 0.5 mg
n=10 Participants
TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 2: TAK-137 2 mg
n=8 Participants
TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 3: TAK-137 5 mg
n=10 Participants
TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 4: TAK-137 10 mg
TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
|
|---|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137
Day 1 (n= 8, 10, 8, 10)
|
1.560 hours
Full Range 2.039 • Interval 1.0 to 3.02
|
1.750 hours
Full Range 22.749 • Interval 1.0 to 4.0
|
2.060 hours
Full Range 35.079 • Interval 1.5 to 4.02
|
4.000 hours
Full Range 113.096 • Interval 1.0 to 4.05
|
—
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137
Day 7 (n= 8, 8, 6, 6)
|
1.015 hours
Interval 1.0 to 2.0
|
1.750 hours
Interval 1.0 to 4.0
|
3.500 hours
Interval 2.0 to 4.0
|
2.000 hours
Interval 1.0 to 3.0
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 7 pre-dose and at multiple timepoints (up to 24 hours) post-dosePopulation: Pharmacokinetic analysis set was defined as all participants who received at least one dose of study drug and had at least one measurable plasma concentration.
Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.
Outcome measures
| Measure |
Cohorts 1-4: Placebo
n=8 Participants
TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
|
Cohort 1: TAK-137 0.5 mg
n=10 Participants
TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 2: TAK-137 2 mg
n=8 Participants
TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 3: TAK-137 5 mg
n=10 Participants
TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 4: TAK-137 10 mg
TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
|
|---|---|---|---|---|---|
|
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-137
Day 7 (n= 8, 8, 6, 4)
|
52.9 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 24.15 • Interval 1.0 to 2.0
|
438.4 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 600.42 • Interval 1.0 to 4.0
|
1224.0 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 689.80 • Interval 2.0 to 4.0
|
3288.5 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 3189.13 • Interval 1.0 to 3.0
|
—
|
|
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-137
Day 1 (n= 8, 10, 8, 10)
|
73.5 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 37.87 • Interval 1.0 to 3.02
|
265.3 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 156.89 • Interval 1.0 to 4.0
|
717.1 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 432.37 • Interval 1.5 to 4.02
|
1442.8 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 621.57 • Interval 1.0 to 4.05
|
—
|
Adverse Events
Cohorts 1-4: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 1: TAK-137 0.5 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2: TAK-137 2 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3: TAK-137 5 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 4: TAK-137 10 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohorts 1-4: Placebo
n=10 participants at risk
TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
|
Cohort 1: TAK-137 0.5 mg
n=8 participants at risk
TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 2: TAK-137 2 mg
n=10 participants at risk
TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 3: TAK-137 5 mg
n=9 participants at risk
TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
|
Cohort 4: TAK-137 10 mg
n=10 participants at risk
TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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
Electroencephalogram abnormal
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
37.5%
3/8 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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
Arthralgia
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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%
3/9 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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
Dyspepsia
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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
Infusion site haematoma
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Heart rate decreased
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood pressure diastolic decreased
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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
Dysuria
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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
Dyspnoea
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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
Hypotension
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug (Day 7).
At each visit the investigator had to document any occurrence of adverse events and 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