Investigation of Food Effect and Gastric ph Increase on the Bioavailability of Faldapravir

Study Overview
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Brief Summary
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The primary objective of this trial is to investigate the effect of food and of gastric pH increase on the relative bioavailability of faldaprevir.

Official Title
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Investigation of the Effect of Food and of Increased Gastric pH on the Relative Bioavailability of a Single Oral Dose of 240 mg Faldaprevir in an Open-label, Randomised, Three-way Cross-over Trial in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: faldaprevir
* Drug: faldaprevir
* Drug: omeprazole
* Drug: faldaprevir


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 1. Healthy male and female subjects Exclusion criteria: 1. Any relevant deviation from healthy condition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Experimental: Reference<br>faldaprevir medium, fasted | Drug: faldaprevir<br>* medium dose of faldaprevir<br>|
| Active Comparator: Test 1<br>faldaprevir medium, fed | Drug: faldaprevir<br>* medium dose of faldaprevir<br>|
| Active Comparator: Test 2<br>faldaprevir medium + omeprazole medium | Drug: omeprazole<br>* medium dose of omeprazole<br>Drug: faldaprevir<br>* medium dose of faldaprevir<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Faldaprevir: Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) | Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 extrapolated to infinity In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration | 
| Faldaprevir: Maximum Measured Concentration (Cmax) | Maximum measured concentration of the faldaprevir in plasma In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Faldaprevir: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the last quantifiable drug plasma concentration In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration |