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Study to Assess Cardiac Conduction of GSK1349572

NCT00996021 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2010-01-25

No results posted yet for this study

Summary

This will be a randomized, partial-blind, placebo-controlled, single dose, cross-over trial investigating the effect of GSK1349572 on cardiac repolarization as compared to placebo in healthy adult males and females. Approximately 42 subjects will be enrolled in this study and will be admitted to the clinic for three separate dosing sessions. Subjects will receive single dose administrations of placebo, a supratherapeutic dose of GSK1349572 (250 mg), and moxifloxacin (400 mg) in random sequence. Safety of subjects will be monitored by clinical observation, measures of vital signs, 12-lead ECGs and clinical laboratory measurements.

Conditions

  • Healthy Subjects

Interventions

DRUG

GSK1349572 250 mg

This is an experimental HIV medication in the integrase inhibitor class.

DRUG

Placebo Suspension

Placebo is a liquid with no drug in it.

DRUG

Moxifloxacin 400 mg

This is an FDA approved antibiotic in the fluoroquinolone class.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2009-11-30
Completion
2009-12-31

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 NCT00996021 on ClinicalTrials.gov