Study to Evaluate the Effect of GSK1265744 on Cardiac Conduction
Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
Summary
This study is being conducted to comply with the Food and Drug Administration (FDA)
recommendation that all new non anti-arrhythmic drugs be assessed for cardiac repolarization
effects through electrocardiographic evaluation. Therefore, this study will evaluate the
effect of GSK1265744 on cardiac conduction as assessed by collection of twelve-lead
continuous digital data in healthy adults. This study will evaluate the effect of three doses
of GSK1265744 on the QT duration corrected for heart rate (QTc) interval as compared to
placebo. Moxifloxacin will be used as a positive control in order to validate the sensitivity
of the study in detecting QTc change. This study consists of three treatment periods (each
separated by 21 day washout period) followed by follow-up visit 10 to 14 days post last
dosing. The total duration of study including follow-up visit will be approximately 62 days.
Approximately 42 subjects will be enrolled such that 34 subjects complete dosing and critical
assessments.
Phase:
Phase 1
Details
Lead Sponsor:
ViiV Healthcare
Collaborator:
GlaxoSmithKline
Treatments:
Cabotegravir Fluoroquinolones Moxifloxacin Norgestimate, ethinyl estradiol drug combination