TAK-020 Relative Bioavailability and Food Effect Study in Healthy Participants
Summary
The purpose of this study is to assess the relative bioavailability of solid oral formulations of TAK-020 in comparison with single dose of TAK-020 oral solution formulation and to evaluate the food effect and potentially the dose proportionality of the optimal oral solid formulation.
Timeline
- Start
- 2016-04-28
- Primary completion
- 2016-08-05
- Completion
- 2016-08-24
Outcome
Mixed primary results
registry analysis (superiority or other test); Part 2: TAK-020 25 mg CCT Fasted vs Part 2: TAK-020 25 mg CCT Fed; p = 0.054; LS Mean Difference 0.685 (90% CI 0.499 to 0.939); ANOVA NCT02723201 ↗
registry analysis (superiority or other test); Part 2: TAK-020 25 mg CCT Fasted vs Part 2: TAK-020 25 mg CCT Fed; p = 0.037; LS Mean Difference 0.836 (90% CI 0.731 to 0.957); ANOVA NCT02723201 ↗
registry analysis (superiority or other test); Part 1: TAK-020 17.5 mg OS vs Part 1: TAK-020 17.5 mg CCT; p <0.001; LS Mean Difference 0.402 (90% CI 0.320 to 0.505); ANOVA NCT02723201 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TAK-020 | Small molecule | 17.5 mg | Oral |
| Subject | TAK-020 | Small molecule | 25 mg | Oral |
Indications
No indication recorded.