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

NCT02293148 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2018-07-24

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-11-17
Primary Completion
2015-03-10
Completion
2015-03-10

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT02293148 on ClinicalTrials.gov