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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: faldaprevir; Drug: omeprazole

• Registration Number: NCT01694706
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-24
• Study First Submitted QC: 2012-09-24
• Study First Posted: 2012-09-27
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2015-07
• Results First Submitted: 2015-07-03
• Results First Submitted QC: 2015-07-03
• Last Update Submitted: 2015-07-03
• Results First Posted: 2015-07-30
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference	faldaprevir	faldaprevir medium, fasted
Test 1	faldaprevir	faldaprevir medium, fed
Test 2	omeprazole	faldaprevir medium + omeprazole medium
Test 2	faldaprevir	faldaprevir medium + omeprazole medium

Primary Outcome Measures

Name	Time	Method
Faldaprevir: Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)	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	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.
Faldaprevir: Maximum Measured Concentration (Cmax)	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	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.

Secondary Outcome Measures

Name	Time	Method
Faldaprevir: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)	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	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.

Trial Locations

Locations (1)

1220.59.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany