MedTrace Logo

The Effect of BI 187004 on the Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P Glycoprotein Substrate (Digoxin)

NCT02254148 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-12-23

No results posted yet for this study

Summary

To assess the influence of BI 187004 on kinetics of cytochrome P450 (CYP) and P glycoprotein (P-gp) probe drugs as a means of predicting drug-drug interactions.

Conditions

  • Healthy

Interventions

DRUG

midazolam

single dose of midazolam given as oral solution (day 1 of visits 2 and 3)

DRUG

caffeine

single dose of caffeine given as tablets (day 1 of visits 2 and 3)

DRUG

digoxin

single dose of digoxin given as tablets (day 3 of visits 2 and 3)

DRUG

warfarin

single dose of warfarin given as tablets (day 1 of visits 2 and 3)

DRUG

omeprazole

single dose of omeprazole given as tablet (day 1 of visits 2 and 3)

DRUG

BI 187004

multiple doses of BI 187004 given as tablets (day 7-12 of visit 2 and day 1-6 of visit 3)

DRUG

metoprolol

single dose of metoprolol given as tablets (day 1 of visits 2 and 3)

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2014-12-31
Completion
2014-12-31

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 NCT02254148 on ClinicalTrials.gov