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| Sponsor: | GlaxoSmithKline |
|---|---|
| Collaborator: |
Shionogi |
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00996021 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Subjects |
Drug: GSK1349572 250 mg Drug: Placebo Suspension Drug: Moxifloxacin 400 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | A Study to Evaluate the Effect of a Single 250 mg Oral Dose of GSK1349572 on Cardiac Conduction as Assessed by 12-lead Electrocardiogram Compared to Placebo and a Single Oral Dose of Moxifloxacin (ING111856). |
| Enrollment: | 42 |
| Study Start Date: | September 2009 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm 1: Experimental
This is a three way crossover study with 3 periods. Subjects will receive a single dose of either GSK1349572 250 mg suspension, placebo suspension or moxifloxacin 400 mg tablet in each of the three periods. The order in which the treatments are given will be randomized. There is a screening visit within 30 days prior to the first dose of study drug and a follow-up visit within 10-14 days after the last dose of study drug.
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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.
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Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 111856 |
| Study First Received: | October 8, 2009 |
| Last Updated: | January 21, 2010 |
| ClinicalTrials.gov Identifier: | NCT00996021 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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GSK1349572 moxifloxacin Avelox QTc |
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Anti-Infective Agents Moxifloxacin Therapeutic Uses Pharmacologic Actions |