drugset / Trial / NCT01721135

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

NCT01721135

Phase 1 Withdrawn GlaxoSmithKline
RandomizedCrossoverDouble-blindTreatment

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 .

Timeline

Start
2010-09
Primary completion
2014-12
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject FIBOFLAPON Small molecule 100 mg Oral
Subject FIBOFLAPON Small molecule 200 mg Oral
Comparator Moxifloxacin Small molecule 400 mg Oral

Indications