A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 19 - 55 |
| Updated: | 1/30/2019 |
| Start Date: | October 18, 2018 |
| End Date: | December 22, 2018 |
A Phase 1, Open-Label, Randomized, Single Dose, 5-Period, 5-Treatment Study to Evaluate the Relative Bioavailability and Effect of Food on TAK-831 Tablet Formulations in Healthy Subjects
The purpose of this study is to assess the oral BA of TAK-831 T3 tablet formulation relative
to TAK-831 T2 tablet formulation under fasting conditions and to assess the effect of food on
the pharmacokinetics (PK) of TAK-831 T3 tablet formulation.
to TAK-831 T2 tablet formulation under fasting conditions and to assess the effect of food on
the pharmacokinetics (PK) of TAK-831 T3 tablet formulation.
The drug being tested in this study is called TAK-831. TAK-831 is being tested in healthy
participants to evaluate the relative BA and effect of food on the PK of TAK-831 tablet
formulation.
The study will enroll approximately 16 participants. Participants will be randomly assigned
(by chance, like flipping a coin) to TAK-831 in 1 of the 4 treatment sequences as following:
- T2 50 mg Fasted + T3 50 mg Fasted + T2 600 mg Fasted + T3 600 mg Fasted + T3 600 mg Fed
- T3 50 mg Fasted + T2 600 mg Fasted + T2 50 mg Fasted + T3 600 mg Fasted + T3 600 mg Fed
- T2 600 mg Fasted + T3 600 mg Fasted + T3 50 mg Fasted + T2 50 mg Fasted + T3 600 mg Fed
- T3 600 mg Fasted + T2 50 mg Fasted + T2 600 mg Fasted + T3 50 mg Fasted + T3 600 mg Fed
All participants will be asked to take tablet of assigned TAK-831 on Day 1 of each treatment
period.
This single center trial will be conducted in the United States. The overall time to
participate in this study is approximately 70 days. Participants will make multiple visits to
the clinic and will be contacted by clinic approximately 14 days after the last dose of study
drug for a follow-up assessment.
participants to evaluate the relative BA and effect of food on the PK of TAK-831 tablet
formulation.
The study will enroll approximately 16 participants. Participants will be randomly assigned
(by chance, like flipping a coin) to TAK-831 in 1 of the 4 treatment sequences as following:
- T2 50 mg Fasted + T3 50 mg Fasted + T2 600 mg Fasted + T3 600 mg Fasted + T3 600 mg Fed
- T3 50 mg Fasted + T2 600 mg Fasted + T2 50 mg Fasted + T3 600 mg Fasted + T3 600 mg Fed
- T2 600 mg Fasted + T3 600 mg Fasted + T3 50 mg Fasted + T2 50 mg Fasted + T3 600 mg Fed
- T3 600 mg Fasted + T2 50 mg Fasted + T2 600 mg Fasted + T3 50 mg Fasted + T3 600 mg Fed
All participants will be asked to take tablet of assigned TAK-831 on Day 1 of each treatment
period.
This single center trial will be conducted in the United States. The overall time to
participate in this study is approximately 70 days. Participants will make multiple visits to
the clinic and will be contacted by clinic approximately 14 days after the last dose of study
drug for a follow-up assessment.
Inclusion Criteria:
1. Body mass index (BMI) greater than or equal to (>=) 18.0 and less than (<) 30.0 kilogram
per square meter (kg/m^2), at Screening.
Exclusion Criteria:
1. History or presence of alcoholism or drug abuse within the past 2 years prior to the
first dosing.
2. Smokes more than 20 cigarettes or equivalent per day within 3 months prior to the
first dose and is unwilling to discontinue use of any tobacco- or nicotine-containing
products during the confinement period(s) of the study.
3. Has been on a diet incompatible with the on-study diet, in the opinion of the
Investigator or designee, within the 30 days prior to the first dosing and throughout
the study.
4. Is lactose intolerant or unable/unwilling to eat the high-fat breakfast.
5. Donation of blood or significant blood loss within 56 days prior to the first dosing.
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