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

• ClinicalTrials.gov Identifier: NCT01694706
• Recruitment Status: Completed
• First Posted: September 27, 2012
• Results First Posted: July 30, 2015
• Last Update Posted: July 30, 2015
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: faldaprevir; Drug: omeprazole	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (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
• Study Start Date: September 2012
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Faldaprevir: Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) [ Time Frame: 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.

2. Faldaprevir: Maximum Measured Concentration (Cmax) [ Time Frame: 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 :

1. Faldaprevir: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy condition

Contacts and Locations

Locations

Germany

1220.59.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim; Boehringer Ingelheim

More Information

Additional Information:

Related Info 

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT01694706 History of Changes
• Other Study ID Numbers: 1220.59; 2012-002941-39 ( EudraCT Number: EudraCT )
• First Posted: September 27, 2012
• Results First Posted: July 30, 2015
• Last Update Posted: July 30, 2015
• Last Verified: July 2015

Additional relevant MeSH terms:

Omeprazole; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action