Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Doses With Titration of TAK-935 in Healthy Japanese Participants (NCT NCT04461483)
NCT ID: NCT04461483
Last Updated: 2022-01-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
33 participants
Primary outcome timeframe
Part 1: Baseline up to Day 8; Part 2: Baseline up to Day 35
Results posted on
2022-01-11
Participant Flow
Participants took part in the study at 1 investigative site in Japan from 13 August 2020 to 14 November 2020.
Healthy Japanese participants were enrolled in the study into two parts: Single Ascending Dose (SAD) (Part 1) and Multiple Dose (MD) titration (Part 2) to receive TAK-935 tablets or TAK-935 placebo-matching tablets.
Participant milestones
| Measure |
Part 1, SAD, Cohorts 1 to 3: Placebo
TAK-935 placebo-matching tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 1: TAK-935 200 mg
TAK-935 200 milligram (mg), tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 2: TAK-935 600 mg
TAK-935 600 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 3: TAK-935 1200 mg
TAK-935 1200 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 2, MD, Cohort 4: Placebo
TAK-935 placebo-matching tablets, orally, twice daily on Days 1 to 21 in fasted state.
|
Part 2, MD, Cohort 4: TAK-935
TAK-935 100 mg, tablets, orally, twice daily on Days 1 to 7, then up-titrated to TAK-935 200 mg, tablets, orally, twice daily, on Days 8 to 14, further up-titrated to TAK-935 300 mg, tablets, orally, twice daily on Days 15 to 21 as multiple doses with titration in the fasted state.
|
|---|---|---|---|---|---|---|
|
Part 1 (Day 1)
STARTED
|
6
|
6
|
6
|
6
|
0
|
0
|
|
Part 1 (Day 1)
COMPLETED
|
6
|
6
|
6
|
6
|
0
|
0
|
|
Part 1 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 (Day 1 to 21)
STARTED
|
0
|
0
|
0
|
0
|
3
|
6
|
|
Part 2 (Day 1 to 21)
COMPLETED
|
0
|
0
|
0
|
0
|
3
|
6
|
|
Part 2 (Day 1 to 21)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Doses With Titration of TAK-935 in Healthy Japanese Participants
Baseline characteristics by cohort
| Measure |
Part 1, SAD, Cohorts 1 to 3: Placebo
n=6 Participants
TAK-935 placebo-matching tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 1: TAK-935 200 mg
n=6 Participants
TAK-935 200 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 2: TAK-935 600 mg
n=6 Participants
TAK-935 600 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 3: TAK-935 1200 mg
n=6 Participants
TAK-935 1200 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 2, MD, Cohort 4: Placebo
n=3 Participants
TAK-935 placebo-matching tablets, orally, twice daily on Days 1 to 21 in fasted state.
|
Part 2, MD, Cohort 4: TAK-935
n=6 Participants
TAK-935 100 mg, tablets, orally, twice daily on Days 1 to 7, then up-titrated to TAK-935 200 mg, tablets, orally, twice daily, on Days 8 to 14, further up-titrated to TAK-935 300 mg, tablets, orally, twice daily on Days 15 to 21 as multiple doses with titration in the fasted state.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.8 years
STANDARD_DEVIATION 12.43 • n=5 Participants
|
39.0 years
STANDARD_DEVIATION 12.71 • n=7 Participants
|
31.5 years
STANDARD_DEVIATION 14.11 • n=5 Participants
|
41.5 years
STANDARD_DEVIATION 11.20 • n=4 Participants
|
37.7 years
STANDARD_DEVIATION 8.39 • n=21 Participants
|
33.5 years
STANDARD_DEVIATION 7.48 • n=8 Participants
|
37.1 years
STANDARD_DEVIATION 11.28 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Region of Enrollment
Japan
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Height
|
170.5 centimeter (cm)
STANDARD_DEVIATION 6.95 • n=5 Participants
|
169.8 centimeter (cm)
STANDARD_DEVIATION 4.02 • n=7 Participants
|
167.0 centimeter (cm)
STANDARD_DEVIATION 8.39 • n=5 Participants
|
173.3 centimeter (cm)
STANDARD_DEVIATION 5.61 • n=4 Participants
|
173.7 centimeter (cm)
STANDARD_DEVIATION 1.53 • n=21 Participants
|
168.2 centimeter (cm)
STANDARD_DEVIATION 2.64 • n=8 Participants
|
170.1 centimeter (cm)
STANDARD_DEVIATION 5.74 • n=8 Participants
|
|
Weight
|
63.78 kilogram (kg)
STANDARD_DEVIATION 4.392 • n=5 Participants
|
59.88 kilogram (kg)
STANDARD_DEVIATION 4.212 • n=7 Participants
|
58.75 kilogram (kg)
STANDARD_DEVIATION 5.410 • n=5 Participants
|
65.47 kilogram (kg)
STANDARD_DEVIATION 7.750 • n=4 Participants
|
65.70 kilogram (kg)
STANDARD_DEVIATION 1.778 • n=21 Participants
|
61.38 kilogram (kg)
STANDARD_DEVIATION 2.865 • n=8 Participants
|
62.2 kilogram (kg)
STANDARD_DEVIATION 5.311 • n=8 Participants
|
|
Body-mass Index (BMI)
|
21.98 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.755 • n=5 Participants
|
20.77 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.206 • n=7 Participants
|
21.05 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 0.822 • n=5 Participants
|
21.75 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.473 • n=4 Participants
|
21.77 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 0.306 • n=21 Participants
|
21.75 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.571 • n=8 Participants
|
21.49 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.326 • n=8 Participants
|
|
Smoking Classification
Never Smoked
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
25 Participants
n=8 Participants
|
|
Smoking Classification
Former Smoker
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Alcohol Classification
Had Daily Consumption
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Alcohol Classification
Had a Few Times Per Week
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Alcohol Classification
Had a Few Times Per Month
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
|
Alcohol Classification
Had no Consumption
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
|
Caffeine Classification
Had Caffeine
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Caffeine Classification
Had no Caffeine
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Part 1: Baseline up to Day 8; Part 2: Baseline up to Day 35Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part 1, SAD, Cohorts 1 to 3: Placebo
n=6 Participants
TAK-935 placebo-matching tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 1: TAK-935 200 mg
n=6 Participants
TAK-935 200 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 2: TAK-935 600 mg
n=6 Participants
TAK-935 600 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 3: TAK-935 1200 mg
n=6 Participants
TAK-935 1200 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 2, MD, Cohort 4: Placebo
n=3 Participants
TAK-935 placebo-matching tablets, orally, twice daily on Days 1 to 21 in fasted state.
|
Part 2, MD, Cohort 4: TAK-935 100 mg
n=6 Participants
TAK-935 100 mg, tablets, orally, twice daily on Days 1 to 7 in fasted state.
|
Part 2, MD, Cohort 4: TAK-935 200 mg
n=6 Participants
TAK-935 200 mg, tablets, orally, twice daily on Days 8 to 14 in fasted state following TAK-935 100 mg, tablet, orally, twice daily.
|
Part 2, MD, Cohort 4: TAK-935 300 mg
n=6 Participants
TAK-935 300 mg, tablets, orally, twice daily on Days 15 to 21 in fasted state following TAK-935 200 mg, tablet, orally, twice daily.
|
|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33.33 percentage of participants
|
16.7 percentage of participants
|
33.33 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dosePopulation: The pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of study drug and had at least 1 estimable PK parameter.
Outcome measures
| Measure |
Part 1, SAD, Cohorts 1 to 3: Placebo
n=6 Participants
TAK-935 placebo-matching tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 1: TAK-935 200 mg
n=6 Participants
TAK-935 200 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 2: TAK-935 600 mg
n=6 Participants
TAK-935 600 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 3: TAK-935 1200 mg
TAK-935 1200 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 2, MD, Cohort 4: Placebo
TAK-935 placebo-matching tablets, orally, twice daily on Days 1 to 21 in fasted state.
|
Part 2, MD, Cohort 4: TAK-935 100 mg
TAK-935 100 mg, tablets, orally, twice daily on Days 1 to 7 in fasted state.
|
Part 2, MD, Cohort 4: TAK-935 200 mg
TAK-935 200 mg, tablets, orally, twice daily on Days 8 to 14 in fasted state following TAK-935 100 mg, tablet, orally, twice daily.
|
Part 2, MD, Cohort 4: TAK-935 300 mg
TAK-935 300 mg, tablets, orally, twice daily on Days 15 to 21 in fasted state following TAK-935 200 mg, tablet, orally, twice daily.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-935
|
413.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 202.4
|
3001 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 47.3
|
9278 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 48.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 7, 14, and 21 pre-dose and at multiple time points (up to 12 hours) post-dosePopulation: The PK analysis set included all participants who received at least 1 dose of study drug and had at least 1 estimable PK parameter. As planned data for this outcome measure was collected, analyzed and reported for dose level TAK-935-100 mg on Day 7, dose level TAK-935-200 mg on Day 14, and TAK-935-300 mg on Day 21.
Outcome measures
| Measure |
Part 1, SAD, Cohorts 1 to 3: Placebo
n=6 Participants
TAK-935 placebo-matching tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 1: TAK-935 200 mg
n=6 Participants
TAK-935 200 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 2: TAK-935 600 mg
n=6 Participants
TAK-935 600 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 3: TAK-935 1200 mg
TAK-935 1200 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 2, MD, Cohort 4: Placebo
TAK-935 placebo-matching tablets, orally, twice daily on Days 1 to 21 in fasted state.
|
Part 2, MD, Cohort 4: TAK-935 100 mg
TAK-935 100 mg, tablets, orally, twice daily on Days 1 to 7 in fasted state.
|
Part 2, MD, Cohort 4: TAK-935 200 mg
TAK-935 200 mg, tablets, orally, twice daily on Days 8 to 14 in fasted state following TAK-935 100 mg, tablet, orally, twice daily.
|
Part 2, MD, Cohort 4: TAK-935 300 mg
TAK-935 300 mg, tablets, orally, twice daily on Days 15 to 21 in fasted state following TAK-935 200 mg, tablet, orally, twice daily.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-935
|
146.5 ng/mL
Geometric Coefficient of Variation 113.1
|
835.5 ng/mL
Geometric Coefficient of Variation 73.8
|
1945 ng/mL
Geometric Coefficient of Variation 37.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dosePopulation: The PK analysis set included all participants who received at least 1 dose of study drug and had at least 1 estimable PK parameter.
Outcome measures
| Measure |
Part 1, SAD, Cohorts 1 to 3: Placebo
n=6 Participants
TAK-935 placebo-matching tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 1: TAK-935 200 mg
n=6 Participants
TAK-935 200 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 2: TAK-935 600 mg
n=6 Participants
TAK-935 600 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 3: TAK-935 1200 mg
TAK-935 1200 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 2, MD, Cohort 4: Placebo
TAK-935 placebo-matching tablets, orally, twice daily on Days 1 to 21 in fasted state.
|
Part 2, MD, Cohort 4: TAK-935 100 mg
TAK-935 100 mg, tablets, orally, twice daily on Days 1 to 7 in fasted state.
|
Part 2, MD, Cohort 4: TAK-935 200 mg
TAK-935 200 mg, tablets, orally, twice daily on Days 8 to 14 in fasted state following TAK-935 100 mg, tablet, orally, twice daily.
|
Part 2, MD, Cohort 4: TAK-935 300 mg
TAK-935 300 mg, tablets, orally, twice daily on Days 15 to 21 in fasted state following TAK-935 200 mg, tablet, orally, twice daily.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-935
|
512.7 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 100.8
|
3538 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 45.8
|
10590 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 42.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dosePopulation: The PK analysis set included all participants who received at least 1 dose of study drug and had at least 1 estimable PK parameter.
Outcome measures
| Measure |
Part 1, SAD, Cohorts 1 to 3: Placebo
n=6 Participants
TAK-935 placebo-matching tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 1: TAK-935 200 mg
n=6 Participants
TAK-935 200 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 2: TAK-935 600 mg
n=6 Participants
TAK-935 600 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 3: TAK-935 1200 mg
TAK-935 1200 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 2, MD, Cohort 4: Placebo
TAK-935 placebo-matching tablets, orally, twice daily on Days 1 to 21 in fasted state.
|
Part 2, MD, Cohort 4: TAK-935 100 mg
TAK-935 100 mg, tablets, orally, twice daily on Days 1 to 7 in fasted state.
|
Part 2, MD, Cohort 4: TAK-935 200 mg
TAK-935 200 mg, tablets, orally, twice daily on Days 8 to 14 in fasted state following TAK-935 100 mg, tablet, orally, twice daily.
|
Part 2, MD, Cohort 4: TAK-935 300 mg
TAK-935 300 mg, tablets, orally, twice daily on Days 15 to 21 in fasted state following TAK-935 200 mg, tablet, orally, twice daily.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1, AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Time of Infinity for TAK-935
|
539.2 h*ng/mL
Geometric Coefficient of Variation 97.2
|
3603 h*ng/mL
Geometric Coefficient of Variation 45.1
|
10660 h*ng/mL
Geometric Coefficient of Variation 42.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dosePopulation: The PK analysis set included all participants who received at least 1 dose of study drug and had at least 1 estimable PK parameter.
Outcome measures
| Measure |
Part 1, SAD, Cohorts 1 to 3: Placebo
n=6 Participants
TAK-935 placebo-matching tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 1: TAK-935 200 mg
n=6 Participants
TAK-935 200 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 2: TAK-935 600 mg
n=6 Participants
TAK-935 600 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 3: TAK-935 1200 mg
TAK-935 1200 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 2, MD, Cohort 4: Placebo
TAK-935 placebo-matching tablets, orally, twice daily on Days 1 to 21 in fasted state.
|
Part 2, MD, Cohort 4: TAK-935 100 mg
TAK-935 100 mg, tablets, orally, twice daily on Days 1 to 7 in fasted state.
|
Part 2, MD, Cohort 4: TAK-935 200 mg
TAK-935 200 mg, tablets, orally, twice daily on Days 8 to 14 in fasted state following TAK-935 100 mg, tablet, orally, twice daily.
|
Part 2, MD, Cohort 4: TAK-935 300 mg
TAK-935 300 mg, tablets, orally, twice daily on Days 15 to 21 in fasted state following TAK-935 200 mg, tablet, orally, twice daily.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1, AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for TAK-935
|
517.8 h*ng/mL
Geometric Coefficient of Variation 99.4
|
3538 h*ng/mL
Geometric Coefficient of Variation 45.8
|
10540 h*ng/mL
Geometric Coefficient of Variation 41.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 7, 14, and 21 pre-dose and at multiple time points (up to 12 hours) post-dosePopulation: The PK analysis set included all participants who received at least 1 dose of study drug and had at least 1 estimable PK parameter. As planned data for this outcome measure was collected, analyzed and reported for dose level TAK-935-100 mg on Day 7, dose level TAK-935-200 mg on Day 14, and TAK-935-300 mg on Day 21.
Outcome measures
| Measure |
Part 1, SAD, Cohorts 1 to 3: Placebo
n=6 Participants
TAK-935 placebo-matching tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 1: TAK-935 200 mg
n=6 Participants
TAK-935 200 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 2: TAK-935 600 mg
n=6 Participants
TAK-935 600 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 3: TAK-935 1200 mg
TAK-935 1200 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 2, MD, Cohort 4: Placebo
TAK-935 placebo-matching tablets, orally, twice daily on Days 1 to 21 in fasted state.
|
Part 2, MD, Cohort 4: TAK-935 100 mg
TAK-935 100 mg, tablets, orally, twice daily on Days 1 to 7 in fasted state.
|
Part 2, MD, Cohort 4: TAK-935 200 mg
TAK-935 200 mg, tablets, orally, twice daily on Days 8 to 14 in fasted state following TAK-935 100 mg, tablet, orally, twice daily.
|
Part 2, MD, Cohort 4: TAK-935 300 mg
TAK-935 300 mg, tablets, orally, twice daily on Days 15 to 21 in fasted state following TAK-935 200 mg, tablet, orally, twice daily.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2, AUCtau,ss: Area Under the Plasma Concentration-time Curve During the Dosing Interval at Steady State for TAK-935
|
202.3 h*ng/mL
Geometric Coefficient of Variation 54.6
|
788.6 h*ng/mL
Geometric Coefficient of Variation 48.9
|
1960 h*ng/mL
Geometric Coefficient of Variation 27.7
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1, SAD, Cohort 1-3: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1, SAD, Cohort 1: TAK-935 200 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1, SAD, Cohort 2: TAK-935 600 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1, SAD, Cohort 3: TAK-935 1200 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2, MD, Cohort 4: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2, MD, Cohort 4: TAK-935 100 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2, MD, Cohort 4: TAK-935 200 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2, MD, Cohort 4: TAK-935 300 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 |
Part 1, SAD, Cohort 1-3: Placebo
n=6 participants at risk
TAK-935 placebo-matching tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 1: TAK-935 200 mg
n=6 participants at risk
TAK-935 200 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 2: TAK-935 600 mg
n=6 participants at risk
TAK-935 600 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 1, SAD, Cohort 3: TAK-935 1200 mg
n=6 participants at risk
TAK-935 1200 mg, tablet, orally, once on Day 1 in fasted state.
|
Part 2, MD, Cohort 4: Placebo
n=3 participants at risk
TAK-935 placebo-matching tablets, orally, twice daily on Days 1to 21 in fasted state.
|
Part 2, MD, Cohort 4: TAK-935 100 mg
n=6 participants at risk
TAK-935 100 mg, tablets, orally, twice daily on Days 1 to 7 in fasted state.
|
Part 2, MD, Cohort 4: TAK-935 200 mg
n=6 participants at risk
TAK-935 200 mg, tablets, orally, twice daily on Days 8 to 14 in fasted state following TAK-935 100 mg, tablet, orally, twice daily.
|
Part 2, MD, Cohort 4: TAK-935 300 mg
n=6 participants at risk
TAK-935 300 mg, tablets, orally, twice daily on Days 15 to 21 in fasted state following TAK-935 200 mg, tablet, orally, twice daily.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
Hiccups
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any 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 were adverse events that started after the first dose of study drug (Baseline) up to Day 8 in Part 1, and up to Day 35 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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