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To determine safety, tolerability and Pharmacokinetics of GSK706769
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | 50mg dose once daily for 7 days. |
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| Cohort B | Experimental | 100mg dose once daily for 8 days. |
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| Cohort C | Experimental | 200mg dose once daily for 8 days. |
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| Cohort D | Experimental | 400mg dose once daily for 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK706769 | Drug | 50mg, 100mg, 200mg, or 400mg |
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| Measure | Description | Time Frame |
|---|---|---|
| GSK706769 safety parameters: the number of adverse events | From Day 1 to the follow up visit. Approximately 19 Days. | |
| GSK706769 safety parameters: clinical safety labs from predose values. | Change from baseline values in clinical chemistry, hematology and urinalysis. | From Day 1 to the follow up visit. Approximately 19 Days. |
| GSK706769 safety parameters: vital signs (blood pressure and heart rate) from predose values | Change from baseline values | From Day 1 to the follow up visit. Approximately 19 days. |
| GSK706769 safety parameters: electrocardiogram (ECG) intervals, ECG rhythm, and ECG axis from predose values. | Change from baseline values | From Day 1 to the follow up visit. Approximately 19 days. |
| GSK706769 and GSK1996847 (metabolite) pharmacokinetic parameters following single dose administration on Day 1, when possible | Area under the plasma concentration time curve (AUC(0-infinity), AUC(0-24)), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), concentration at 24 hours post dose (C24), terminal half-life (t1/2), absorption lag time (tlag), apparent clearance (CL/F), metabolite-to-parent molar ratios for AUC(0-t) and Cmax; and following last repeat administration on Day 7 or 8: AUC(0-infinity), concentration at end of dosing interval (Ctau), Cmax, tlag, tmax, t1/2, and CL/F, metabolite-to-parent molar ratios for AUC(0-tau) and Cmax on Day 7 or 8. | Day 7 or 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma AUC(0-t), AUC(0-infinity), and CL/F of midazolam, with and without GSK706769 co-administration | Day -1 and Day 8 | |
| Plasma AUC(0-t) and Cmax of GSK706769 and GSK1996847 | on Day 7 (fasted) and Day 8 (fed). |
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Inclusion Criteria:
Exclusion Criteria:
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. This includes subjects with a history of known or suspected sulfa related hypersensitivity.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Madison | Wisconsin | 53704 | United States |
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| Label | URL |
|---|---|
| Results for study CRR111382 can be found on the GSK Clinical Study Register. | View source |
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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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| Placebo | Other | Placebo |
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| GSK706769 and GSK1996847 Day 7 AUC(0-t), Cmax, and Ct compared to Day 1 AUC(0-24), Cmax, and C24, respectively, to estimate accumulation ratios (R) for AUC, Cmax, and Ct. | Day 1 and Day 7 |
| Pre-morning dose concentrations (Ct) on Day 3 through 7 to assess the achievement of steady state of GSK706769 and GSK1996847 following repeat administration. | Day 3 through 7 |
| Day 7 AUC(0-t), Cmax and Ct of GSK706769 and GSK1996847 at different doses for the assessment of dose proportionality. | Day -1 and Day 7 |
| 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 |