A Study to Determine the Bioavailability and Food Effect of a Single TAK-935 Dose in Healthy Participants
Summary
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.
Timeline
- Start
- 2016-09-12
- Primary completion
- 2016-10-12
- Completion
- 2016-11-09
Outcome
Mixed primary results
registry analysis (superiority or other test); TAK-935 300 mg Tablets Fed vs TAK-935 300 mg Tablets Fasted; p = 0.002; LS Mean Ratio 0.403 (90% CI 0.262 to 0.618); ANOVA NCT02906813 ↗
registry analysis (superiority or other test); TAK-935 300 mg Tablets Fed vs TAK-935 300 mg Tablets Fasted; p = 0.281; LS Mean Ratio 0.889 (90% CI 0.738 to 1.070); ANOVA NCT02906813 ↗
registry analysis (superiority or other test); TAK-935 300 mg Tablets Fed vs TAK-935 300 mg Tablets Fasted; p = 0.355; LS Mean Ratio 0.894 (90% CI 0.726 to 1.100); ANOVA NCT02906813 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Soticlestat | Small molecule | 300 mg | Oral |
Indications
No indication recorded.