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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects. Part A will evaluate the relative bioavailability of two new tablet formulations compared to the current tablet formulation of GSK1349572 at 50 mg administered as single doses each comprising of two 25 mg tablets. Pharmacokinetic samples from Part A will be analyzed and, if at least one of the new formulations meets appropriate criteria and is selected, Part B will be a single-sequence design conducted to evaluate food effect of the selected new tablet formulation at one dose level. A subset of subjects enrolled in Part A will continue in Part B. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 7-28 days after the last dose of study drug.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Subjects will be randomized in a three-way crossover design to receive a single dose of each of three different tablet formulations of GSK1349572 50 mg (2 tablets). Formulation AP, AW and AX. |
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| Part B | Experimental | A total of 18 subjects who complete Part A will return for Part B. Subjects from Part A will be asked to participate on a first come first served basis until there are 18 subjects, at which time enrolment to Part B will be closed. Part B will be a three way crossover design using either formulation AW or AX depending upon the results from Part A. Subjects will receive a single dose of 50 mg GSK1349572 with either a low fat, moderate fat or high fat meal in each period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1349572 formulation AP | Drug | GSK1349572 50 mg single dose fasted. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma GSK1349572 AUC(0-infinity), AUC(0-t), and Cmax. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma GSK1349572 t½, tlag, tmax, C24, Vdss/F, CL/F, and MRT. | 48 hours | |
| Safety and tolerability parameters, including adverse events, concurrent medication, clinical laboratory screens, ECG, and vital signs assessments. | 10 weeks |
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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 | Austin | Texas | 78744 | United States |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
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| GSK1349572 formulation AW |
| Drug |
GSK1349572 formulation AW 50 mg single dose in Part A and 75 to 200 mg fasted or with moderate or high fat meal in Part B. |
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| GSK1349572 formulation AX | Drug | GSK1349572 formulation AX 50 mg in Part A and 75-200 mg fasted or with a moderate or high fat meal in Part B |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |