Completed

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

What is being tested

faldaprevir

+ faldaprevir

+ omeprazole

Drug

Who is being recruted

From 18 to 50 Years

+2 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: September 2012

See protocol details

Summary

Principal SponsorBoehringer Ingelheim

Last updated: July 30, 2015

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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

NCT01694706

Principal SponsorBoehringer Ingelheim

Last updated: July 30, 2015

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate

1. Healthy male and female subjects

1 exclusion criteria prevent from participating

1. Any relevant deviation from healthy condition

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

faldaprevir medium, fasted

Group II

Active Comparator

faldaprevir medium, fed

Group III

Active Comparator

faldaprevir medium + omeprazole medium

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

1220.59.1 Boehringer Ingelheim Investigational Site

Biberach, GermanyOpen 1220.59.1 Boehringer Ingelheim Investigational Site in Google Maps

CompletedOne Study Center