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This is a single-center, randomized, open-label, balanced, 3 way crossover study (3 periods) in healthy adult subjects. During each period, subjects will receive a single dose of GSK1265744 oral formulation in the fasted state and serial PK sampling for up to 168 hours (8 days) and safety assessments will be performed. Each period will be separated by a washout period of at least 14 days and a follow-up visit will occur 10 to 14 days after the last dose of study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1265744 Na Salt Tablets | Experimental | Subjects will receive single dose of GSK1265744 sodium salt (30 mg) tablet on Day 1 of the respective period per randomized sequence, orally in fasted condition, with 240 milliliter (mL) of water. |
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| GSK1265744 Free Acid Nanomilled Capsules | Experimental | Subjects will receive single dose of GSK1265744 free acid nanomilled (30 mg) capsule on Day 1 of the respective period per randomized sequence, orally in fasted condition, with 240 mL of water. |
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| GSK1265744 Free Acid Micronized Capsules | Experimental | Subjects will receive single dose of GSK1265744 free acid micronized (30 mg) capsule on Day 1 of the respective period per randomized sequence, orally in fasted condition, with 240 mL of water. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1265744 Na Salt Tablets | Drug | Each tablet contains 30 mg of GSK1265744 sodium salt and excipients. |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite of PK parameters following single oral dose administration of GSK1265744 | Plasma GSK1265744 PK parameters: area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time AUC(0-infinity); AUC from time zero to time t, AUC(0-t), and maximum observed concentration, Cmax. | For 168 hours post dose (36 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of PK parameters following single oral dose administration of GSK1265744 | Following plasma GSK1265744 PK parameters will be evaluated: concentration at 24 hour post-dose (C24), terminal phase half-life (t1/2), lag time before observation of drug concentrations in sampled matrix (tlag), time of occurrence of Cmax (tmax), percentage of AUC(0-infinity) obtained by extrapolation (%AUCex), apparent clearance following oral dosing (CL/F). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Overland Park | Kansas | 66211 | United States |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
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| GSK1265744 Free Acid Nanomilled Capsules | Drug | Each capsule contains 30 mg of nanomilled and spray dried GSK1265744 free acid, blended with excipients. |
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| GSK1265744 Free Acid Micronized Capsules | Drug | Each capsule contains 30 mg of micronized GSK1265744 free acid, blended with excipients. |
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| For 168 hours post each dose of GSK1265744 (36 days) |
| Safety and tolerability as assessed by the collection of adverse events | 50 days |
| Safety and tolerability as assessed by change from baseline in clinical laboratory tests | Clinical laboratory tests include hematology, clinical chemistry, urinalysis tests. | 50 days |
| Safety and tolerability as assessed by change from baseline in electrocardiogram (ECG) | 50 days |
| Safety and tolerability as assessed by change from baseline in vital signs | Vital sign measurements will include systolic and diastolic blood pressure and pulse rate. | 50 days |
| Safety and tolerability as assessed by the collection of concurrent medication. | 50 days |
| 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 |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |