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Assessment of the Effect of BI 201335 on the QT Interval in Healthy Female and Male Subjects

NCT02182310 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2014-07-18

No results posted yet for this study

Summary

To demonstrate that BI 201335 does not prolong the QT interval more than placebo.

To assess the tolerability of 1200 mg of BI 201335 as single dose in female subjects (double-blind, randomised, placebo-controlled) before inclusion of female subjects in the cross-over part of the trial.

Conditions

  • Healthy

Interventions

DRUG

BI 201335 low dose

DRUG

BI 201335 placebo

DRUG

Moxifloxacin

DRUG

BI 201335 high dose

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2008-10-31

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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 NCT02182310 on ClinicalTrials.gov