NCT02293148

Single Dose, Pharmacokinetic, Safety, Tolerability and QTc Study of GSK1278863 in Healthy Volunteers

A Two-part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a High, Single Oral Dose of GSK1278863 (Part A), and a Randomized, Single-blind, Placebo- and Positive-controlled, Four-way Crossover Study to Assess the Effect of Single, Oral Dose of GSK1278863 on Cardiac Repolarization (Part B) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is being performed to comply with regulatory requirements that all new non-antiarrhythmic drugs must be assessed for potential effects on cardiac repolarization through electrocardiographic evaluation in a 'Thorough QT/ Corrected QT interval (TQT)' study. This will be a two part study, Part A will be an open-label, single oral dose study design in order to evaluate the pharmacokinetics, safety and tolerability of a 500 milligram (mg) dose of GSK1278863 and Part B will be a single-blind, randomized, placebo-controlled, single, oral dose, four-way crossover study design. Parts A and B will be conducted in healthy adult subjects with 12-lead electrocardiograms (ECGs), clinical laboratory safety tests, vital sign measurements, physical examinations, adverse event reports, and pharmacokinetic samples collected throughout the study.

Conditions

• Anaemia

Interventions

Type	Name	Description
DRUG	GSK1278863 75 mg	A round, biconvex, white film coated tablet available in two doses (25 and 100 mg)
DRUG	GSK1278863 500 mg	A round, biconvex, white film coated tablet available in two doses (25 and 100 mg)
DRUG	Moxifloxacin 400 mg	Oblong, dull red, film-coated, convex tablets with M400 on one side
DRUG	Placebo matching GSK1278863	A round, biconvex, white film coated tablet as matching placebo for GSK1278863
DRUG	Placebo matching Moxifloxacin	Capsule shaped white film coated tablet as matching placebo for Moxifloxacin

Timeline

• Start date: 2014-11-17
• Primary completion: 2015-03-10
• Completion: 2015-03-10
• First posted: 2014-11-18
• Last updated: 2018-07-24

Locations

1 site across 1 country: United States