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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 to assess the oral bioavailability of three GSK2248761 Wet Bead Milled (WBM) tablet formulations manufactured by three different processes relative to the GSK2248761 WBM capsule formulation (Part A) and the effect of a moderate-fat meal on the bioavailability of the selected WBM tablet formulation (Part B).
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 |
|---|---|---|---|
| Periods 1 - 4 | Experimental | Subjects will be randomized in a cross over fashion to receive the GSK2248761 WBM capsule formulation or one of three WBM tablet formulations in one of four sequences. |
|
| Period 5 | Experimental | Subjects in Part B will receive a formulation of GSK2248761 200mg WBM Tablet chosen from Periods 1 - 4 in part A in the fed state (moderate fat meal). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2248761 WBM Capsule | Drug | 200 mg GSK2248761 WBM capsule (reference) 2 X100mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma GSK2248761 Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity)) | 5 weeks | |
| Plasma GSK2248761 Area under the concentration-time curve over the dosing interval (AUC (0 - t)) | 5 weeks | |
| Plasma GSK2248761 observed concentration 24 hours after dose (C24) | 5 weeks | |
| Plasma GSK2248761 Maximum observed concentration (Cmax) | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability parameters, including adverse events | 5 weeks | |
| concurrent medication | 5 weeks | |
| Clinical laboratory screens |
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Inclusion Criteria:
Exclusion Criteria:
Note: this does not include plasma donation.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Buffalo | New York | 14202 | United States |
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| GSK2248761 WBM Tablet Formulation 1 |
| Drug |
GSK2248761 WBM Tablet 200mg manufacturing process 1 |
|
| GSK2248761 WBM Tablet Formulation 2 | Drug | GSK2248761 WBM Tablet 200mg manufacturing process 2 |
|
| GSK2248761 WBM Tablet Formulation 3 | Drug | GSK2248761 WBM Tablet 200mg manufacturing process 3 |
|
| GSK2248761 WBM Tablet | Drug | GSK2248761 WBM tablet 200mg manufacturing process 1, 2, or 3 chosen from Period 1 - 4 |
|
| 5 weeks |
| Electrocardiograms (ECG) | 5 weeks |
| Vital sign assessments (systolic and diastolic blood pressure and pulse) | 5 weeks |
| Plasma GSK2248761 terminal phase half life (t½) | 5 weeks |
| Plasma GSK2248761 Lag time before observation of drug concentrations (tlag) | 5 weeks |
| Plasma GSK2248761 Time of occurrence of Cmax (tmax) | 5 weeks |
| Plasma GSK2248761 Percentage of AUC(0-infinity) obtained by extrapolation (%AUCex) | 5 weeks |
| Plasma GSK2248761 Time of last quantifiable concentration (tlast) | 5 weeks |
| Plasma GSK2248761 Apparent clearance following oral dosing (CL/F) | 5 weeks |
| 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 |
| 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 |
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