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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 effect of up to three formulations on the relative bioavailability of GSK2248761 100mg administered with and without food. Part A will evaluate two new formulations compared to the current formulation. Part B will evaluate one additional formulation if the bioavailability of the two formulations in Part A do not meet pre-specified criteria. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 7-10 days after the last dose of study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Subjects will be randomized in a three way crossover design to either a single dose of GSK2248761 100mg Gelucire capsule administered with food and a single dose of 100mg of formulation 1 or a single dose of 100mg of formulation 3 administered in the fed and fasted state |
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| Part B | Experimental | A total of twelve subjects who complete Part A will participate in Part B. Subjects from Part A will be asked to participate on a first come first serve basis until there are 12 subjects, at which time enrolment to Part B will be closed. Part B will be a 2 way cross over study design. Subjects will be randomized to one of a single dose of GSK2248761 100mg Formulation 2 or 4 (based on the evaluation of Part A data) administered with food or in the fasted state. Subjects in Part B will not receive the reference formulation since they previously received this in Part A |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2248761 formulation 1 | Drug | 100mg GSK2248761 formulation 1- fasted 100mg GSK2248761 formulation 1 - with food (moderate fat meal) |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve zero to infinity of plasma GSK2248761 | Plasma samples will be collected for the analysis of AUC (0-inf) of GSK2248761. | Up to 5 weeks |
| AUC from time zero to end of dosing interval AUC (0-tau) | Plasma samples will be collected for the analysis AUC (0-tau) of GSK2248761. | Up to 5 weeks |
| Maximum concentration (Cmax) of GSK2248761 | Plasma samples will be collected for the analysis of Cmax of GSK2248761. | Up to 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Terminal half life (t1/2) of GSK2248761 | Plasma samples will be collected for the analysis of t1/2 of GSK2248761. | Up to 5 weeks |
| Lag time before observation of drug concentration (tlag) of GSK2248761 |
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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 | Buffalo | New York | 14202 | United States |
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| Label | URL |
|---|---|
| Results for study 113391 can be found on the ViiV Clinical Study Register. | View source |
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| GSK2248761 reference formulation | Drug | GSK2248761 100mg Gelucire reference capsule with food |
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| GSK2248761 formulation 3 | Drug | 100mg GSK2248761 formulation 3 fasted 100mg GSK2248761 formulation 3 with food (moderate fat meal) |
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| GSK2248761 formulation 2 or 4 | Drug | 100mg GSK2248761 formulation 2 or 4 - fasted 100mg GSK2248761 formulation 2 or 4 - with food (moderate fat meal) |
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Plasma samples will be collected for the analysis of tlag of GSK2248761.
| Up to 5 weeks |
| Time to Cmax of GSK2248761 | Plasma samples will be collected for the analysis of Tmax of GSK2248761. | Up to 5 weeks |
| Percentage of AUC obtained by extrapolation (%AUCex) for GSK2248761 | Plasma samples will be collected for the analysis of %AUCex for GSK2248761. | Up to 5 weeks |
| Apparent clearance following oral dosing (CL/F) for GSK2248761 | Plasma samples will be collected for the analysis of CL/F for GSK2248761. | Up to 5 weeks |
| Number of participants with seious adverse events (SAEs) and non-serious adverse events (non-SAEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. | Up to 5 weeks |
| Number of participants with concurrent medication | Number of participants with concurrent medication will be summarized. | Up to 5 weeks |
| Number of participants with abnormal clinical laboratory parameters | Blood samples will be collected for the analysis of clinical laboratory parameters. | Up to 5 weeks |
| Number of participants with abnormal electrocardiogram (ECG) values | 12-lead ECG will be obtained using an ECG machine. Participants will be in supine or a semi-recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes before ECGs are recorded. | Up to 5 weeks |
| Number of participants with abnormal vital signs | Vital signs will be measured at indicated time points in semi-supine position after 5 minutes rest. | Up to 5 weeks |
| ID | Term |
|---|---|
| D007239 | Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| 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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