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| Name | Class |
|---|---|
| Shionogi | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1349572 250 mg | Drug | This is an experimental HIV medication in the integrase inhibitor class. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in QTcF for GSK1349572. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of GSK1349572 as assessed by 12-lead ECGs, vital signs, adverse events, and clinical laboratory tests. | 24 hours | |
| Change from baseline in QTcB, QTci, QT, and HR for GSK1349572 | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Baltimore | Maryland | 21225 | United States |
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| ID | Term |
|---|---|
| C562325 | dolutegravir |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Placebo Suspension |
| Drug |
Placebo is a liquid with no drug in it. |
|
| Moxifloxacin 400 mg | Drug | This is an FDA approved antibiotic in the fluoroquinolone class. |
|
|
| Change from baseline in QTcF, QTcB, QTci, QT, and HR for placebo | 24 hours |
| Change from baseline in QTcF, QTcB, QTci, QT, and HR for moxifloxacin | 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) | 24 hours |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |