drugset / Trial / NCT01983566
Effect of Food and Increased Gastric pH Value on Bioavailability of a Single Dose of BI 207127 in Healthy Caucasian and Japanese Subjects
RandomizedCrossoverOpen-labelTreatment
Summary
The purpose of this trial is to investigate the effect of food with different fat content and of gastric pH increase (mediated by multiple dosing of omeprazole) on the relative bioavailability of deleobuvir.
Timeline
- Start
- 2013-11
- Primary completion
- 2014-01
- Completion
- 2014-01
Outcome
Missed primary endpoint
registry analysis (non-inferiority or equivalence test); Dele Fasted vs Dele Low Fat; p = 0.3944; Geometric mean ratio (%) 115.80 (90% CI 63.52 to 211.11) NCT01983566 ↗
registry P-value for ratio outside interval 80-125%. NCT01983566 ↗
registry analysis (non-inferiority or equivalence test); Dele Fasted vs Dele Low Fat; p = 0.3674; Geometric mean ratio (%) 114.83 (90% CI 74.803 to 176.281) NCT01983566 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Deleobuvir | Small molecule | — | — |
| Subject | Omeprazole | Other / unclassified | 40 mg | — |
Indications
No indication recorded.