Effect of Food and Increased Gastric pH Value on Bioavailability of a Single Dose of BI 207127 in Healthy Caucasian and Japanese Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 207127 high fat
* Drug: BI 207127 with Omeprazole
* Drug: BI 207127
* Drug: BI 207127 low fat


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy males or females according to the investigators assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests. Subjects will be either Caucasian or Japanese (first generation Japanese: born in Japan with parents of Japanese descent, and not more than 5 years out of Japan, documented by medical interview and by appropriate materials - e.g. passport, birth certificate, etc) Age 20 to 35 years (incl.) BMI 18.5 to 25 kg/m2 (incl.) Exclusion criteria: Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg Any laboratory value outside the reference range that the investigator considers to be of clinical relevance Any evidence of a concomitant disease judged clinically relevant by the investigator Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s) Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BI 207127 fasted<br>patient to receive BI 207127 as a single dose in fasted state | Drug: BI 207127<br>* BI 207127 as a single dose in fasted state<br>|
| Experimental: BI 207127 high fat<br>patient to receive BI 207127 as a single dose after a high fat breakfast | Drug: BI 207127 high fat<br>* BI 207127 as a single dose after a high fat breakfast<br>|
| Experimental: BI 207127 low fat<br>patient to receive BI 207127 as a single dose after a low fat breakfast | Drug: BI 207127 low fat<br>* BI 207127 as a single dose after a low fat breakfast<br>|
| Experimental: BI 207127 with Omeprazole<br>patient to receive BI 207127 as a single dose after 4 days treatment with Omeprazole 40 mg once a day | Drug: BI 207127 with Omeprazole<br>* BI 207127 as a single dose after 4 days treatment of Omeprazole 40 mg once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(0-tz) | Area under the concentration-time curve of deleobuvir in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) | 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 | 
| Cmax | Maximum measured concentration of deleobuvir in plasma (Cmax) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(0-inf) | Area under the concentration-time curve of deleobuvir in plasma over the time interval from 0 extrapolated to infinity (AUC0-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 |