A Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 Tablet Formulation
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/20/2019 |
| Start Date: | April 4, 2017 |
| End Date: | May 26, 2017 |
A Randomized, Open-Label, Single-Dose, 2-Period, Crossover Design, Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 T2 Tablet Formulation in Healthy Subjects
The purpose of this study is to determine the pharmacokinetic (PK) of a single oral dose of
TAK-831 400 milligram (mg) in the fasted state and to estimate the effect of food on the PK
of a single oral dose of TAK-831 400 mg when administered as tablet formulation in healthy
participants.
TAK-831 400 milligram (mg) in the fasted state and to estimate the effect of food on the PK
of a single oral dose of TAK-831 400 mg when administered as tablet formulation in healthy
participants.
The drug being tested in this study is called TAK-831. TAK-831 is being tested in healthy
participants under fasting and fed conditions in order to determine the effect of food on the
PK of single oral dose of TAK-831 tablet formulation. The study will enroll approximately 16
participants. Participants will be randomly and equally assigned (by chance, like flipping a
coin) to 1 of the 2 treatment sequences following as:
- TAK-831 400 mg Fasted + TAK-831 400 mg Fed
- TAK-831 400 mg Fed + TAK-831 400 mg Fasted All participants will be asked to take single
oral dose of TAK-831 tablet at the same time on Day 1 of each Intervention Period. This
single center trial will be conducted in the United States. The overall time to
participate in this study is 23 days. Participants will visit the clinic on Day -1 and
remained confined until Day 3 of Intervention Period 1 and 2. A washout period of
minimum 7 days will be maintained between the doses in each Intervention Period.
Participants will make 3 visits to the clinic on Days 4, 6 and 8 on each Intervention
Period and will be contacted by telephone 14 days after the last dose of study drug (Day
23) for a follow-up assessment.
participants under fasting and fed conditions in order to determine the effect of food on the
PK of single oral dose of TAK-831 tablet formulation. The study will enroll approximately 16
participants. Participants will be randomly and equally assigned (by chance, like flipping a
coin) to 1 of the 2 treatment sequences following as:
- TAK-831 400 mg Fasted + TAK-831 400 mg Fed
- TAK-831 400 mg Fed + TAK-831 400 mg Fasted All participants will be asked to take single
oral dose of TAK-831 tablet at the same time on Day 1 of each Intervention Period. This
single center trial will be conducted in the United States. The overall time to
participate in this study is 23 days. Participants will visit the clinic on Day -1 and
remained confined until Day 3 of Intervention Period 1 and 2. A washout period of
minimum 7 days will be maintained between the doses in each Intervention Period.
Participants will make 3 visits to the clinic on Days 4, 6 and 8 on each Intervention
Period and will be contacted by telephone 14 days after the last dose of study drug (Day
23) for a follow-up assessment.
Inclusion Criteria:
1. Weighs greater than or equal to (>=) 45 kilogram (kg) and has a body mass index (BMI)
between 18.0 and 30.0 kilogram per square meter (kg/m^2), inclusive at Screening.
Exclusion Criteria:
1. Has received TAK-831 in a previous clinical study.
2. Has poor peripheral venous access.
3. Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including
plasmapheresis), or had a transfusion of any blood product within 45 days prior to
first dose of study drug.
4. Has any dietary restrictions or preferences that may interfere with the conduct of the
study.
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