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A Study to Evaluate the Effect of Two Different Repeat Doses of GSK2190915 on the QTc Interval.

NCT01721135 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2013-08-21

No results posted yet for this study

Summary

This study is a randomized, placebo controlled, four way crossover, in which the the effect of GSK2190915 on the QTc interval is assessed. Healthy subjects will recieve a 5 day course of each of the following; oral placebo, GSK2190915 100mg, GSK2190915 1000mg and moxifloxacin 400mg (single dose) with a weeks washout prior to starting the next course. Key assessments include a 12- lead electrocardiogram and pharmacokinetic testing. Safety will be assessed by blood pressure, heart rate, clinical laboratory safety tests and collection of adverse events .

Conditions

Interventions

DRUG

GSK2190915 100mg

Film coated oral tablet

DRUG

GSK2190915 200mg

Film coated oral tablet

DRUG

moxifloxacin 400mg

Film coated oral tablet

DRUG

moxifloxacin placebo

Film coated oral tablet

DRUG

GSK2190915 placebo

Film coated oral tablet

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
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 NCT01721135 on ClinicalTrials.gov