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Effects of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail in Healthy Volunteers

NCT02182336 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2014-07-18

No results posted yet for this study

Summary

The objective of this trial was to quantify the effect of oral single-dose (480 mg) and steady-state BI 201335 NA (240 mg BID) on intestinal and hepatic cytochrome P450 (CYP) and P-glycoprotein (P-gp) probe drugs as a means of predicting drug interactions. The AUCs for the probe drugs caffeine, warfarin, omeprazole, dextromethorphan, midazolam, and digoxin were assessed.

Conditions

  • Healthy

Interventions

DRUG

BI 201335 NA

1. 480 mg BI 201335 NA in the morning, 240 mg BI 201335 NA in the evening of day 10 2. 240 mg BI 201335 NA bid from day 11 to 23

DRUG

Caffeine

days 1, 10 and 19

DRUG

Warfarin sodium

days 1, 10 and 19

DRUG

Vitamin K

days 1, 10 and 19

DRUG

Omeprazole

days 1, 10 and 19

DRUG

Dextromethorphan hydrobromide

days 1, 10 and 19

DRUG

Midazolam HCl solution

Days 3 and 21

DRUG

Midazolam HCl oral syrup

days 1, 10 and 19

DRUG

Digoxin

Days 2 and 20

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2008-09-30

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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 NCT02182336 on ClinicalTrials.gov