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Multiple Doses of BI 207127 NA, BI 201335 NA Followed by the Combination of BI 207127 NA and BI 201335 NA in Healthy Male Volunteers

NCT02182401 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2014-07-18

No results posted yet for this study

Summary

Study to investigate the pharmacokinetic drug-drug interaction potential of BI 207127 NA and BI 201335 NA on each other at steady-state and to quantify the effect of BI 207127 NA, and BI 207127 NA combined with BI 201335 NA, on the activity of CYP 2C9 and CYP 3A4 using the probe substrates tolbutamide (CYP 2C9) and midazolam (CYP 3A4).

Conditions

  • Healthy

Interventions

DRUG

BI 207127 NA

Days 3-8 and days 25-30

DRUG

BI 201335 NA

Days 15-30

DRUG

Midazolam

Days 1, 7, 23 and 29

DRUG

Tolbutamide

Days 1, 7, 23 and 29

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-08-31

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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 NCT02182401 on ClinicalTrials.gov