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GSK2248761 formulation 1 · 1 trial · 2 indications
Plasma samples will be collected for the analysis of AUC (0-inf) of GSK2248761.
Plasma samples will be collected for the analysis AUC (0-tau) of GSK2248761.
Plasma samples will be collected for the analysis of Cmax of GSK2248761.
| Arm | Type | Description |
|---|---|---|
| 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 |
| 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 |
| Name | Type | Description |
|---|---|---|
| GSK2248761 formulation 1 | DRUG | 100mg GSK2248761 formulation 1- fasted 100mg GSK2248761 formulation 1 - with food (moderate fat meal) |
| GSK2248761 reference formulation | DRUG | GSK2248761 100mg Gelucire reference capsule with food |
| GSK2248761 formulation 3 | DRUG | 100mg GSK2248761 formulation 3 fasted 100mg GSK2248761 formulation 3 with food (moderate fat meal) |
| GSK2248761 formulation 2 or 4 | DRUG | 100mg GSK2248761 formulation 2 or 4 - fasted 100mg GSK2248761 formulation 2 or 4 - with food (moderate fat meal) |
Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital signs, laboratory tests, and ECGs. * Male or female between 18 and 50 years of age inclusive, at the time of signing the infor...
GSK2248761 formulation 1 is an investigational small molecule being developed for the treatment of Human Immunodeficiency Virus (HIV) infections. It is intended to address infectious disease indications, specifically HIV Infections. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
GSK2248761 formulation 1 is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of this investigational drug for the treatment of HIV infections.
GSK2248761 formulation 1 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies such as the FDA. The drug is being studied in early-stage trials to assess its bioavailability and food effects in healthy volunteers.
GSK2248761 formulation 1 has one completed clinical trial, NCT01031472, titled 'A Study to Assess Relative Bioavailability and Food Effect of New Formulations of GSK2248761'. This Phase 1 study enrolled 24 participants in the United States and evaluated the drug's pharmacokinetics in healthy volunteers.
GSK2248761 formulation 1 is a specific formulation of the drug GSK2248761. The clinical trial NCT01031472 was designed to assess the relative bioavailability and food effect of new formulations of GSK2248761, indicating that formulation 1 is one of several versions being studied for potential development.