NCT02257398

Placebo and Moxifloxacin Controlled Cardiac Conduction Study of GSK2140944 in Healthy Volunteers

A Phase I, Randomized, Double-Blinded, Placebo- and Moxifloxacin-Controlled, 4-Period Crossover Study to Evaluate the Effect of GSK2140944 on Cardiac Conduction as Assessed by 12-lead Electrocardiogram in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is Phase I, 4-period, randomized, active-and placebo-controlled, double-blind crossover, single-dose study to evaluate the effects of a therapeutic (1000 milligram \[mg\]) and supratherapeutic (1800 mg) dose of GSK2140944 with a positive control (moxifloxacin 400 mg) and placebo on the corrected QT interval (QTc) as assessed by continuous 12-lead Holter electrocardiograms (ECGs) in approximately 55 healthy volunteers. All subjects will receive single doses of GSK2140944 1000 mg, GSK2140944 1800 mg, moxifloxacin 400 mg, and placebo in a randomized sequence. A double-dummy approach will be used to maintain blinding. Thus, on each dosing day, moxifloxacin or moxifloxacin placebo and GSK2140944 or placebo will be administered. Subjects will be screened within 30 days prior to entry to the clinic. Subjects will report to the clinical unit on Day -2 of Period 1 and on Day -1 in subsequent periods. Subjects will remain confined until check out procedures have been completed on Day 3 (5 days confinement in Period 1 and 4 days in the following 3 periods). There will be a washout of at least 7 days between doses. The follow-up visit will occur 7-10 days after the final dose. Total duration of the study (from screening to the follow-up visit) will be approximately 60 days.

Conditions

• Infections, Respiratory Tract

Interventions

Type	Name	Description
DRUG	GSK2140944	GSK2140944 is available in dose strength 1000 mg and 1800 mg for single IV dose over 2 hours administration as a pale yellow to greyish yellow cake for reconstitution
DRUG	GSK2140944 placebo	GSK2140944 placebo is 0.9% sodium chloride available for single IV dose over 2 hours administration.
DRUG	Moxifloxacin	Moxifloxacin is available as pinkish red tablet with dose strength 400 mg for single oral dose to be administered in the morning in the fasted state with approximately 240 mL of water.
DRUG	Moxifloxacin placebo	Moxifloxacin placebo is available as white, film-coated tablet. containing nonactive material for single oral dose to be administered in the morning in the fasted state with approximately 240 mL of water.

Timeline

• Start date: 2014-10-06
• Primary completion: 2015-03-02
• Completion: 2015-03-02
• First posted: 2014-10-06
• Last updated: 2017-07-13

Locations

1 site across 1 country: United States