Trial Outcomes & Findings for A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of TAK-828 Escalating Multiple-Doses in Healthy Participants (NCT NCT02817516)
NCT ID: NCT02817516
Last Updated: 2019-07-17
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Baseline up to 10 days after last dose of study drug (Day 24)
Results posted on
2019-07-17
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 30 June 2016 to 22 August 2016.
Non-Japanese healthy participants were enrolled in Part 1 to receive TAK-828 as multiple rising dose of: 15 milligram (mg) in Cohort 1, 45 mg in Cohort 2, and 75 mg in Cohort 3. Study was terminated before the start of 100 mg in Part 1 Cohort 4, and 45 mg and 100 mg in Japanese participants in Part 2 due to findings from 13-week toxicology study.
Participant milestones
| Measure |
Part 1 Cohorts 1 to 3: Placebo
TAK-828 placebo-matching solution, orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 1: TAK-828 15 mg
TAK-828 15 mg, solution (0.2 milligram per milliliter \[mg/mL\] or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 2: TAK-828 45 mg
TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 3: TAK-828 75 mg
TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Part 1 Cohorts 1 to 3: Placebo
TAK-828 placebo-matching solution, orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 1: TAK-828 15 mg
TAK-828 15 mg, solution (0.2 milligram per milliliter \[mg/mL\] or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 2: TAK-828 45 mg
TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 3: TAK-828 75 mg
TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
|---|---|---|---|---|
|
Overall Study
Other
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of TAK-828 Escalating Multiple-Doses in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part 1 Cohorts 1 to 3: Placebo
n=6 Participants
TAK-828 placebo-matching solution, orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 1: TAK-828 15 mg
n=6 Participants
TAK-828 15 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 2: TAK-828 45 mg
n=6 Participants
TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 3: TAK-828 75 mg
n=6 Participants
TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.2 years
STANDARD_DEVIATION 7.78 • n=5 Participants
|
40.3 years
STANDARD_DEVIATION 8.45 • n=7 Participants
|
26.5 years
STANDARD_DEVIATION 3.73 • n=5 Participants
|
37.0 years
STANDARD_DEVIATION 14.63 • n=4 Participants
|
34.8 years
STANDARD_DEVIATION 10.27 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Height
|
172.3 centimeter (cm)
STANDARD_DEVIATION 11.72 • n=5 Participants
|
171.8 centimeter (cm)
STANDARD_DEVIATION 9.15 • n=7 Participants
|
175.3 centimeter (cm)
STANDARD_DEVIATION 2.42 • n=5 Participants
|
168.5 centimeter (cm)
STANDARD_DEVIATION 3.94 • n=4 Participants
|
172.0 centimeter (cm)
STANDARD_DEVIATION 7.67 • n=21 Participants
|
|
Weight
|
77.75 kilogram (kg)
STANDARD_DEVIATION 15.209 • n=5 Participants
|
72.23 kilogram (kg)
STANDARD_DEVIATION 6.696 • n=7 Participants
|
77.45 kilogram (kg)
STANDARD_DEVIATION 9.702 • n=5 Participants
|
73.45 kilogram (kg)
STANDARD_DEVIATION 11.232 • n=4 Participants
|
75.22 kilogram (kg)
STANDARD_DEVIATION 10.679 • n=21 Participants
|
|
Body Mass Index (BMI)
|
25.97 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.645 • n=5 Participants
|
24.48 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.525 • n=7 Participants
|
25.17 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.743 • n=5 Participants
|
25.87 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.974 • n=4 Participants
|
25.37 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.733 • n=21 Participants
|
|
Smoking Classification
Never smoked
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Smoking Classification
Ex-smoker
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Alcohol Classification
Never drunk
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Alcohol Classification
Current drinker
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Alcohol Classification
Ex-drinker
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Caffeine/Xanthine Consumption
Had caffeine/xanthine consumption
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Caffeine/Xanthine Consumption
Had no caffeine/xanthine consumption
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 10 days after last dose of study drug (Day 24)Population: The safety set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part 1 Cohorts 1 to 3: Placebo
n=6 Participants
TAK-828 placebo-matching solution, orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 1: TAK-828 15 mg
n=6 Participants
TAK-828 15 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 2: TAK-828 45 mg
n=6 Participants
TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 3: TAK-828 75 mg
n=6 Participants
TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
|---|---|---|---|---|
|
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
|
16.7 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
16.7 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to 10 days after last dose of study drug (Day 24)Population: The safety set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part 1 Cohorts 1 to 3: Placebo
n=6 Participants
TAK-828 placebo-matching solution, orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 1: TAK-828 15 mg
n=6 Participants
TAK-828 15 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 2: TAK-828 45 mg
n=6 Participants
TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 3: TAK-828 75 mg
n=6 Participants
TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
|---|---|---|---|---|
|
Percentage of Participants Who Discontinued the Treatment Due to an Adverse Event (AE)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to 10 days after last dose of study drug (Day 24)Population: The safety set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part 1 Cohorts 1 to 3: Placebo
n=6 Participants
TAK-828 placebo-matching solution, orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 1: TAK-828 15 mg
n=6 Participants
TAK-828 15 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 2: TAK-828 45 mg
n=6 Participants
TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 3: TAK-828 75 mg
n=6 Participants
TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
|---|---|---|---|---|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to 10 days after last dose of study drug (Day 24)Population: The safety set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part 1 Cohorts 1 to 3: Placebo
n=6 Participants
TAK-828 placebo-matching solution, orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 1: TAK-828 15 mg
n=6 Participants
TAK-828 15 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 2: TAK-828 45 mg
n=6 Participants
TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 3: TAK-828 75 mg
n=6 Participants
TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
|---|---|---|---|---|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
Systolic blood pressure (BP) supine <85 mmHg
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
Systolic BP standing<85millimeter of mercury(mmHg)
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
Diastolic BP supine less than (<) 50 mm Hg
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
Diastolic BP standing <50 mm Hg
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
Pulse rate supine <50 beats per minute (bpm)
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
Pulse rate 5 minutes supine <50 bpm
|
16.7 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
Pulse rate 1 minute standing <50 bpm
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
Pulse rate 3 minute standing <50 bpm
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
Pulse rate 3 minute standing greater than 120 bpm
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
Temperature <35.6 Celsius
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to 10 days after last dose of study drug (Day 24)Population: The safety set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part 1 Cohorts 1 to 3: Placebo
n=6 Participants
TAK-828 placebo-matching solution, orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 1: TAK-828 15 mg
n=6 Participants
TAK-828 15 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 2: TAK-828 45 mg
n=6 Participants
TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 3: TAK-828 75 mg
n=6 Participants
TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
|---|---|---|---|---|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) at Least Once Post-dose
Heart Rate <50 bpm
|
16.7 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) at Least Once Post-dose
QT Interval greater than or equalto 460millisecond
|
16.7 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1 and 7 pre-dose and at multiple time points (up to 24 hours) post-dose and Day 14 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: Pharmacokinetic (PK) set included all participants who received at least 1 dose of study drug, had at least 1 measurable plasma/urine concentration of TAK-828F. PK set where data at specified time points was available. PK data was not collected for Day 7 and 14 Part 1 Cohort 3, as participants received last dose on Day 6 due to study termination.
Outcome measures
| Measure |
Part 1 Cohorts 1 to 3: Placebo
n=6 Participants
TAK-828 placebo-matching solution, orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 1: TAK-828 15 mg
n=6 Participants
TAK-828 15 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 2: TAK-828 45 mg
n=6 Participants
TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 3: TAK-828 75 mg
TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-828 (TAK-828F)
Day 1
|
1170 nanogram per milliliter (ng/mL)
Standard Deviation 302
|
3750 nanogram per milliliter (ng/mL)
Standard Deviation 562
|
9680 nanogram per milliliter (ng/mL)
Standard Deviation 1580
|
—
|
|
Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-828 (TAK-828F)
Day 7
|
1480 nanogram per milliliter (ng/mL)
Standard Deviation 230
|
4610 nanogram per milliliter (ng/mL)
Standard Deviation 619
|
—
|
—
|
|
Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-828 (TAK-828F)
Day 14
|
1310 nanogram per milliliter (ng/mL)
Standard Deviation 345
|
4600 nanogram per milliliter (ng/mL)
Standard Deviation 524
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 7 pre-dose and at multiple time points (up to 24 hours) post-dose and Day 14 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: PK set included all participants who received at least 1 dose of study drug, had at least 1 measurable plasma/urine concentration of TAK-828F. PK set where data at specified time points was available. PK data was not collected for Day 7 and 14 Part 1 Cohort 3, as participants received last dose on Day 6 due to study termination.
Outcome measures
| Measure |
Part 1 Cohorts 1 to 3: Placebo
n=6 Participants
TAK-828 placebo-matching solution, orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 1: TAK-828 15 mg
n=6 Participants
TAK-828 15 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 2: TAK-828 45 mg
n=6 Participants
TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 3: TAK-828 75 mg
TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-828F
Day 1
|
1.0 hours
Interval 0.5 to 2.0
|
1.0 hours
Interval 0.5 to 1.0
|
1.0 hours
Interval 0.5 to 2.05
|
—
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-828F
Day 7
|
1.0 hours
Interval 0.5 to 2.05
|
0.5 hours
Interval 0.5 to 1.0
|
—
|
—
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-828F
Day 14
|
1.0 hours
Interval 0.5 to 1.0
|
0.5 hours
Interval 0.5 to 1.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohorts 1 and 2: Days 1 and 7 pre-dose and at multiple time points (up to 24 hours) post-dose and Day 14 pre-dose and at multiple time points (up to 72 hours) post-dose; Cohort 3: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dosePopulation: PK set included all participants who received at least 1 dose of study drug, had at least 1 measurable plasma/urine concentration of TAK-828F. PK set where data at specified time points was available. PK data was not collected for Day 7 and 14 Part 1 Cohort 3, as participants received last dose on Day 6 due to study termination.
Outcome measures
| Measure |
Part 1 Cohorts 1 to 3: Placebo
n=6 Participants
TAK-828 placebo-matching solution, orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 1: TAK-828 15 mg
n=6 Participants
TAK-828 15 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 2: TAK-828 45 mg
n=6 Participants
TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 3: TAK-828 75 mg
TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
|---|---|---|---|---|
|
AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-828F
Day 1
|
5090 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 1300
|
15400 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 1360
|
40000 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 5870
|
—
|
|
AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-828F
Day 7
|
6730 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 1320
|
17900 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 3060
|
—
|
—
|
|
AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-828F
Day 14
|
6890 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 1540
|
20600 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 3860
|
—
|
—
|
Adverse Events
Part 1 Cohort 3: TAK-828 75 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 Cohorts 1 to 3: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 Cohort 1: TAK-828 15 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 Cohort 2: TAK-828 45 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 Cohort 3: TAK-828 75 mg
n=6 participants at risk
TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohorts 1 to 3: Placebo
n=6 participants at risk
TAK-828 placebo-matching solution, orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 1: TAK-828 15 mg
n=6 participants at risk
TAK-828 15 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
Part 1 Cohort 2: TAK-828 45 mg
n=6 participants at risk
TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1 to 13, and once in the morning of Day 14 in healthy non-Japanese participants.
|
|---|---|---|---|---|
|
Eye disorders
Dry eye
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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
Frequent bowel movements
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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
Muscle twitching
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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
Pain in extremity
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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 postural
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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
Syncope
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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 • TEAEs are adverse events that started after the first dose of double-blind study drug and no more than 10 days (Day 24) after the last dose of double-blind study drug
At each visit the investigator had to document any occurrence of adverse events and 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