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Completed

NCT Number: NCT01694706

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

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

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1220.59.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and female subjects

Exclusion criteria

  • Any relevant deviation from healthy condition

Treatment and study plan

Faldaprevir

Drug

medium dose of faldaprevir

Omeprazole

Drug

medium dose of omeprazole

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 27, 2012
Registry last updated
Jul 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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