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Effect of Food and Increased Gastric pH Value on Bioavailability of a Single Dose of BI 207127 in Healthy Caucasian and Japanese Subjects

NCT01983566 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-05-16

Study results available
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Summary

The purpose of this trial is to investigate the effect of food with different fat content and of gastric pH increase (mediated by multiple dosing of omeprazole) on the relative bioavailability of deleobuvir.

Conditions

  • Healthy

Interventions

DRUG

BI 207127 high fat

BI 207127 as a single dose after a high fat breakfast

DRUG

BI 207127 with Omeprazole

BI 207127 as a single dose after 4 days treatment of Omeprazole 40 mg once a day

DRUG

BI 207127

BI 207127 as a single dose in fasted state

DRUG

BI 207127 low fat

BI 207127 as a single dose after a low fat breakfast

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01983566 on ClinicalTrials.gov