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

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

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)

Trial Locations (1)

Unknown

1307.19.1 Boehringer Ingelheim Investigational Site, Biberach

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY