Study to Assess Cardiac Conduction of GSK1349572
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|ClinicalTrials.gov Identifier: NCT00996021|
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : January 25, 2010
|Condition or disease||Intervention/treatment||Phase|
|Healthy Subjects||Drug: GSK1349572 250 mg Drug: Placebo Suspension Drug: Moxifloxacin 400 mg||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|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).|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||December 2009|
Experimental: Arm 1
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.
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.
Other Name: AVELOX. AVELOX is a registered trademark of Bayer Aktiengesellschaft
- Change from baseline in QTcF for GSK1349572. [ Time Frame: 24 hours ]
- Safety and tolerability of GSK1349572 as assessed by 12-lead ECGs, vital signs, adverse events, and clinical laboratory tests. [ Time Frame: 24 hours ]
- Change from baseline in QTcB, QTci, QT, and HR for GSK1349572 [ Time Frame: 24 hours ]
- Change from baseline in QTcF, QTcB, QTci, QT, and HR for placebo [ Time Frame: 24 hours ]
- Change from baseline in QTcF, QTcB, QTci, QT, and HR for moxifloxacin [ Time Frame: 24 hours ]
- AUC(0-24), AUC(0-t), AUC(0-tau), Cmax, tmax, CL/F, Vdz/F, and t1/2 from plasma concentrations of GSK1349572 and moxifloxacin (if needed) [ Time Frame: 24 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996021
|United States, Maryland|
|GSK Investigational Site|
|Baltimore, Maryland, United States, 21225|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|