Bioavailability and Food Effect Study of Two Formulations of TAK-906
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy Volunteers
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Both males and females
Description
The drug being tested in this study is called TAK-906. This study will compare the pharmacokinetics (PK) of single oral dose of 50 mg tablet (test [Treatment B]) relative to single oral dose of 50 mg capsule (reference [Treatment A]) under fasted conditions. The study will also explore the effect of...
The drug being tested in this study is called TAK-906. This study will compare the pharmacokinetics (PK) of single oral dose of 50 mg tablet (test [Treatment B]) relative to single oral dose of 50 mg capsule (reference [Treatment A]) under fasted conditions. The study will also explore the effect of food on 50 mg tablet formulation (Treatment C: high-fat/high-calorie meal) on TAK-906 PK following tablet administration relative to the fasted state (Treatment B). The study will enroll approximately 24 participants. Participants will be randomly assigned to 1 of the 2 treatment sequences. This single-center trial will be conducted in the United States. The overall time to participate in this study is approximately 60 days. Participants will be followed up for up to 14 days after the last dose of study drug for a follow-up assessment.
Tracking Information
- NCT #
- NCT04831502
- Collaborators
- Not Provided
- Investigators
- Study Director: Study Director Takeda
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