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

This study has been completed.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: September 24, 2012
Last updated: June 12, 2013
Last verified: June 2013

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

Condition Intervention Phase
Drug: faldaprevir
Drug: omeprazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 120 hours after drug intake ] [ Designated as safety issue: No ]
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 120 hours after drug intake ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) [ Time Frame: up to 120 hours after drug intake ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: September 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reference
faldaprevir medium, fasted
Drug: faldaprevir
medium dose of faldaprevir
Active Comparator: Test 1
faldaprevir medium, fed
Drug: faldaprevir
medium dose of faldaprevir
Active Comparator: Test 2
faldaprevir medium + omeprazole medium
Drug: omeprazole
medium dose of omeprazole
Drug: faldaprevir
medium dose of faldaprevir


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy condition

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Please refer to this study by its identifier: NCT01694706

1220.59.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Identifier: NCT01694706     History of Changes
Other Study ID Numbers: 1220.59, 2012-002941-39
Study First Received: September 24, 2012
Last Updated: June 12, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses processed this record on July 01, 2015