Single Dose, Pharmacokinetic, Safety, Tolerability and QTc Study of GSK1278863 in Healthy Volunteers
Status:
Completed
Trial end date:
2015-03-10
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Fluoroquinolones Glycine Moxifloxacin Norgestimate, ethinyl estradiol drug combination