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

NCT ID: NCT01694706

Last Updated: 2015-07-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reference

faldaprevir medium, fasted

Group Type EXPERIMENTAL

faldaprevir

Intervention Type DRUG

medium dose of faldaprevir

Test 1

faldaprevir medium, fed

Group Type ACTIVE_COMPARATOR

faldaprevir

Intervention Type DRUG

medium dose of faldaprevir

Test 2

faldaprevir medium + omeprazole medium

Group Type ACTIVE_COMPARATOR

omeprazole

Intervention Type DRUG

medium dose of omeprazole

faldaprevir

Intervention Type DRUG

medium dose of faldaprevir

Interventions

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faldaprevir

medium dose of faldaprevir

Intervention Type DRUG

faldaprevir

medium dose of faldaprevir

Intervention Type DRUG

omeprazole

medium dose of omeprazole

Intervention Type DRUG

faldaprevir

medium dose of faldaprevir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. Healthy male and female subjects

Exclusion Criteria

1\. Any relevant deviation from healthy condition
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1220.59.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2012-002941-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1220.59

Identifier Type: -

Identifier Source: org_study_id

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