Investigation of the Effect of Food and of Increased Gastric pH on the Relative Bioavailability of Deleobuvir Following Single Oral Administration in Healthy Caucasian and Japanese Subjects (an Open-label, Randomised, Four-way Crossover Study)
Overview
- Phase
- Phase 1
- Intervention
- BI 207127
- Conditions
- Healthy
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- AUC(0-tz)
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI 207127 fasted
patient to receive BI 207127 as a single dose in fasted state
Intervention: BI 207127
BI 207127 high fat
patient to receive BI 207127 as a single dose after a high fat breakfast
Intervention: BI 207127 high fat
BI 207127 low fat
patient to receive BI 207127 as a single dose after a low fat breakfast
Intervention: BI 207127 low fat
BI 207127 with Omeprazole
patient to receive BI 207127 as a single dose after 4 days treatment with Omeprazole 40 mg once a day
Intervention: BI 207127 with Omeprazole
Outcomes
Primary Outcomes
AUC(0-tz)
Time Frame: 1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration
Area under the concentration-time curve of deleobuvir in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Cmax
Time Frame: 1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration
Maximum measured concentration of deleobuvir in plasma (Cmax)
Secondary Outcomes
- AUC(0-inf)(1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration)