Trial Outcomes & Findings for A Food Effect Study of TAK-385 Final Formulation (NCT NCT02792062)
NCT ID: NCT02792062
Last Updated: 2017-12-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Day 1: Pre-dose and at multiple time points (up to 120 hrs) post-dose
Results posted on
2017-12-18
Participant Flow
Participants took part in the study at 1 investigative site in Japan from 04 July 2016 to 31 August 2016.
Healthy premenopausal adult female participants were enrolled and randomized in this 3 period cross over study in 1 of 6 administration sequences to receive TAK-385 40 milligram (mg) under fasted conditions without breakfast, before breakfast, or after breakfast.
Participant milestones
| Measure |
TAK-385: Fasted+ Before Breakfast + After Breakfast
TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hour (hr) overnight fast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 3.
|
TAK-385: Before Breakfast+ After Breakfast + Fasted
TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 3.
|
TAK-385: After Breakfast+ Fasted + Before Breakfast
TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 3.
|
TAK-385: Fasted+ After Breakfast + Before Breakfast
TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 3.
|
TAK-385: Before Breakfast+ Fasted + After Breakfast
TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 3.
|
TAK-385: After Breakfast+ Before Breakfast + Fasted
TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 3.
|
|---|---|---|---|---|---|---|
|
Intervention Period 1 (6 Days)
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Intervention Period 1 (6 Days)
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Intervention Period 1 (6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period (at Least 14 Days)
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Washout Period (at Least 14 Days)
COMPLETED
|
1
|
2
|
2
|
2
|
2
|
2
|
|
Washout Period (at Least 14 Days)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Intervention Period 2 (6 Days)
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Intervention Period 2 (6 Days)
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Intervention Period 2 (6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Intervention Period 3 (6 Days)
STARTED
|
1
|
2
|
2
|
2
|
2
|
2
|
|
Intervention Period 3 (6 Days)
COMPLETED
|
1
|
2
|
2
|
2
|
2
|
2
|
|
Intervention Period 3 (6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
TAK-385: Fasted+ Before Breakfast + After Breakfast
TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hour (hr) overnight fast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 3.
|
TAK-385: Before Breakfast+ After Breakfast + Fasted
TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 3.
|
TAK-385: After Breakfast+ Fasted + Before Breakfast
TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 3.
|
TAK-385: Fasted+ After Breakfast + Before Breakfast
TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 3.
|
TAK-385: Before Breakfast+ Fasted + After Breakfast
TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 3.
|
TAK-385: After Breakfast+ Before Breakfast + Fasted
TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 3.
|
|---|---|---|---|---|---|---|
|
Washout Period (at Least 14 Days)
Voluntary Withdrawal
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Food Effect Study of TAK-385 Final Formulation
Baseline characteristics by cohort
| Measure |
TAK-385: Fasted+ Before Breakfast + After Breakfast
n=2 Participants
TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hour (hr) overnight fast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 3.
|
TAK-385: Before Breakfast+ After Breakfast + Fasted
n=2 Participants
TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 3.
|
TAK-385: After Breakfast+ Fasted + Before Breakfast
n=2 Participants
TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 3.
|
TAK-385: Fasted+ After Breakfast + Before Breakfast
n=2 Participants
TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 3.
|
TAK-385: Before Breakfast+ Fasted + After Breakfast
n=2 Participants
TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 3.
|
TAK-385: After Breakfast+ Before Breakfast + Fasted
n=2 Participants
TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 3.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
26.5 years
STANDARD_DEVIATION 4.95 • n=5 Participants
|
25.0 years
STANDARD_DEVIATION 7.07 • n=7 Participants
|
33.0 years
STANDARD_DEVIATION 12.73 • n=5 Participants
|
29.0 years
STANDARD_DEVIATION 2.83 • n=4 Participants
|
31.5 years
STANDARD_DEVIATION 13.44 • n=21 Participants
|
23.0 years
STANDARD_DEVIATION 4.24 • n=10 Participants
|
28.0 years
STANDARD_DEVIATION 7.34 • n=115 Participants
|
|
Sex/Gender, Customized
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Region of Enrollment
Japan
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=10 Participants
|
12 participants
n=115 Participants
|
|
Height
|
153.5 centimeter (cm)
STANDARD_DEVIATION 2.12 • n=5 Participants
|
160.5 centimeter (cm)
STANDARD_DEVIATION 3.54 • n=7 Participants
|
156.0 centimeter (cm)
STANDARD_DEVIATION 4.24 • n=5 Participants
|
155.0 centimeter (cm)
STANDARD_DEVIATION 0.00 • n=4 Participants
|
156.0 centimeter (cm)
STANDARD_DEVIATION 0.00 • n=21 Participants
|
155.0 centimeter (cm)
STANDARD_DEVIATION 7.07 • n=10 Participants
|
156.0 centimeter (cm)
STANDARD_DEVIATION 3.59 • n=115 Participants
|
|
Weight
|
52.45 kilogram (kg)
STANDARD_DEVIATION 3.041 • n=5 Participants
|
53.55 kilogram (kg)
STANDARD_DEVIATION 4.031 • n=7 Participants
|
47.50 kilogram (kg)
STANDARD_DEVIATION 4.950 • n=5 Participants
|
46.45 kilogram (kg)
STANDARD_DEVIATION 0.071 • n=4 Participants
|
52.95 kilogram (kg)
STANDARD_DEVIATION 0.071 • n=21 Participants
|
50.70 kilogram (kg)
STANDARD_DEVIATION 5.940 • n=10 Participants
|
50.60 kilogram (kg)
STANDARD_DEVIATION 3.980 • n=115 Participants
|
|
Body Mass Index (BMI)
|
22.20 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 0.707 • n=5 Participants
|
20.75 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 0.636 • n=7 Participants
|
19.40 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 0.990 • n=5 Participants
|
19.30 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 0.000 • n=4 Participants
|
21.70 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 0.000 • n=21 Participants
|
21.00 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 0.566 • n=10 Participants
|
20.73 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.213 • n=115 Participants
|
|
Smoking Classification
Never smoked
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Smoking Classification
Ex-smoker
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Alcohol Classification
Drinks a few days per week
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Alcohol Classification
Drinks a few days per month
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Alcohol Classification
Never drinks
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Caffeine Consumption
Caffeine consumption
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Caffeine Consumption
No caffeine consumption
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose and at multiple time points (up to 120 hrs) post-dosePopulation: The PK analysis set included all participants who received the study drug, had no major protocol violation, fulfilled the minimum protocol specifications, and had data available for the PK analysis. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
Outcome measures
| Measure |
TAK-385 40 mg Fasted
n=12 Participants
TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
|
TAK-385 40 mg Before Breakfast
n=12 Participants
TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
|
TAK-385 40 mg After Breakfast
n=11 Participants
TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
|
|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-385
|
23.44 nanogram per milliliter (ng/mL)
Standard Deviation 17.822
|
29.05 nanogram per milliliter (ng/mL)
Standard Deviation 22.868
|
10.94 nanogram per milliliter (ng/mL)
Standard Deviation 9.3726
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dosePopulation: The PK analysis set included all participants who received the study drug, had no major protocol violation, fulfilled the minimum protocol specifications, and had data available for the PK analysis. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
Outcome measures
| Measure |
TAK-385 40 mg Fasted
n=12 Participants
TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
|
TAK-385 40 mg Before Breakfast
n=12 Participants
TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
|
TAK-385 40 mg After Breakfast
n=11 Participants
TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
|
|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385
|
160.5 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 75.187
|
139.1 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 65.653
|
79.65 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 33.426
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dosePopulation: The PK analysis set included all participants who received the study drug, had no major protocol violation, fulfilled the minimum protocol specifications, and had data available for the PK analysis. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
Outcome measures
| Measure |
TAK-385 40 mg Fasted
n=12 Participants
TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
|
TAK-385 40 mg Before Breakfast
n=12 Participants
TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
|
TAK-385 40 mg After Breakfast
n=11 Participants
TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
|
|---|---|---|---|
|
AUC(0-120): Area Under the Plasma Concentration-time Curve From Time 0 to 120 Hours Postdose for TAK-385
|
149.3 ng*hr/mL
Standard Deviation 70.354
|
130.2 ng*hr/mL
Standard Deviation 61.549
|
73.25 ng*hr/mL
Standard Deviation 30.726
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dosePopulation: The PK analysis set included all participants who received the study drug, had no major protocol violation, fulfilled the minimum protocol specifications, and had data available for the PK analysis. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
Outcome measures
| Measure |
TAK-385 40 mg Fasted
n=12 Participants
TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
|
TAK-385 40 mg Before Breakfast
n=12 Participants
TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
|
TAK-385 40 mg After Breakfast
n=11 Participants
TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
|
|---|---|---|---|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-385
|
149.3 ng*hr/mL
Standard Deviation 70.354
|
130.2 ng*hr/mL
Standard Deviation 61.549
|
73.25 ng*hr/mL
Standard Deviation 30.726
|
SECONDARY outcome
Timeframe: Day 1 up to 12 days after the last dose of study drug (Day 41)Population: The safety analysis set included all participants who received at least one dose of the study drug. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
Outcome measures
| Measure |
TAK-385 40 mg Fasted
n=12 Participants
TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
|
TAK-385 40 mg Before Breakfast
n=12 Participants
TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
|
TAK-385 40 mg After Breakfast
n=11 Participants
TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
|
|---|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) or Serious TEAEs.
TEAEs
|
5 participants
|
5 participants
|
3 participants
|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) or Serious TEAEs.
Serious TEAEs
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 up to 12 days after last dose of study drug (Day 41)Population: The safety analysis set included all participants who received at least one dose of the study drug. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
Outcome measures
| Measure |
TAK-385 40 mg Fasted
n=12 Participants
TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
|
TAK-385 40 mg Before Breakfast
n=12 Participants
TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
|
TAK-385 40 mg After Breakfast
n=11 Participants
TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
|
|---|---|---|---|
|
Number of Participants With TEAEs Related to Vital Signs (Presyncope)
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 up to 12 days after last dose of study drug (Day 41)Population: The safety analysis set included all participants who received at least one dose of the study drug. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
Outcome measures
| Measure |
TAK-385 40 mg Fasted
n=12 Participants
TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
|
TAK-385 40 mg Before Breakfast
n=12 Participants
TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
|
TAK-385 40 mg After Breakfast
n=11 Participants
TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
|
|---|---|---|---|
|
Number of Participants With TEAEs Related to Body Weight
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 up to 12 days after last dose of study drug (Day 41)Population: The safety analysis set included all participants who received at least one dose of the study drug. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
Outcome measures
| Measure |
TAK-385 40 mg Fasted
n=12 Participants
TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
|
TAK-385 40 mg Before Breakfast
n=12 Participants
TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
|
TAK-385 40 mg After Breakfast
n=11 Participants
TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
|
|---|---|---|---|
|
Number of Participants With TEAEs Related to Electrocardiograms (ECG)
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 up to 12 days after last dose of study drug (Day 41)Population: The safety analysis set included all participants who received at least one dose of the study drug. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
Clinical laboratory tests included hematology, serum chemistry, and urinalysis.
Outcome measures
| Measure |
TAK-385 40 mg Fasted
n=12 Participants
TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
|
TAK-385 40 mg Before Breakfast
n=12 Participants
TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
|
TAK-385 40 mg After Breakfast
n=11 Participants
TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
|
|---|---|---|---|
|
Number of Participants With TEAEs Related to Clinical Laboratory Tests
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
TAK-385 40 mg Fasted
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
TAK-385 40 mg Before Breakfast
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
TAK-385 40 mg After Breakfast
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 |
TAK-385 40 mg Fasted
n=12 participants at risk
TAK-385 40 mg, tablets, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast, once on Day 1 of either intervention period 1, 2, or 3.
|
TAK-385 40 mg Before Breakfast
n=12 participants at risk
TAK-385 40 mg, tablets, orally, before 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
|
TAK-385 40 mg After Breakfast
n=11 participants at risk
TAK-385 40 mg, tablets, orally, after 30 minutes of taking breakfast, once on Day 1 of either intervention period 1, 2, or 3.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
8.3%
1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
9.1%
1/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
8.3%
1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
18.2%
2/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
0.00%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
0.00%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
0.00%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
8.3%
1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
0.00%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
8.3%
1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
0.00%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
25.0%
3/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
25.0%
3/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
9.1%
1/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
8.3%
1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
8.3%
1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
9.1%
1/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 12 days (Day 41) after the last dose of study drug
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
|
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