Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Phase 1, Randomized, Open-Label, Single-Dose, 3-Way Crossover Study to Assess the Relative Bioavailability of a TAK-648 Tablet Compared With a TAK-648 Oral Solution, and to Assess the Effect of Food on the Bioavailability of a TAK-648 Tablet in Healthy Participants
The purpose of this study is to assess the relative bioavailability of a TAK-648 tablet compared with a TAK-648 oral solution, and to assess the effect of food on the bioavailability of a TAK-648 tablet in healthy participants.
This study will assess the relative Bioavailability (BA) of TAK-648 tablet compared with
that of TAK-648 solution and the effect of food on the BA of the TAK-648 tablet.
The study will enroll approximately 24 healthy participants. Participants will be randomly
assigned to one of the three treatment sequences:
- TAK-648 tablet in fed state, followed by TAK-648 tablet in fasted state, followed by
TAK-648 oral solution in fasted state
- TAK-648 tablet in fasted state, followed by TAK-648 oral solution in fasted state,
followed by TAK-648 tablet in fed state
- TAK-648 oral solution in fasted state, TAK-648 tablet in fed state, TAK-648 tablet in
fasted state The dosing in a period and the subsequent period will be separated by a
minimum 7-day washout interval. Participants will be asked to take single dose of
TAK-648 tablet or oral solution on Day 1 of each period.
This single-center trial will be conducted in the United States. Participants will make 4
visits to the clinic including three 4-day periods of confinement to the clinic, and will be
contacted by telephone 30 days after last dose of study drug for a follow-up assessment.
;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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