Healthy Volunteers Clinical Trial
Official title:
A Phase 1 Bioavailability and Food Effect Study to Compare Tablet Versus Solution Formulation and to Assess the Effect of Food on the Bioavailability of a Single TAK-935 Dose in Healthy Subjects
The purpose of this study is to assess the relative bioavailability (BA) of 300 milligram (mg) TAK-935 tablets compared to 300 mg of TAK-935 solution and to determine the effect of food on the BA of TAK-935 300 mg tablets in healthy adult participants.
The drug being tested in this study is called TAK-935. The study will look at the relative BA
of TAK-935 300 mg tablets compared to a TAK-935 300 mg oral solution and will assess the
effect of food on the BA of TAK-935 300 mg tablets in healthy adult participants.
The study will enroll approximately 9 participants. Participants will be randomly assigned
(by chance, like flipping a coin) to one of the 3 treatment sequences:
- TAK-935 (300 mg Tablets Fed + 300 mg Tablets Fasted + 300 mg Solution Fasted)
- TAK-935 (300 mg Tablets Fasted + 300 mg Solution Fasted + 300 mg Tablets Fed)
- TAK-935 (300 mg Solution Fasted + 300 mg Tablets Fed + 300 mg Tablets Fasted)
Administration of each dose will be separated by a washout period of at least 3 days.
Participants will be asked to take single dose of TAK-935 tablet or oral solution 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 39 days. Participants will remain confined to the clinic from
Day 1 of Intervention Period 1 to Day 3 of Intervention Period 3 and will be contacted by
telephone 30 days after last dose of TAK-935 for a follow-up assessment.
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