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Also known as GSK3640254 bis-hydrochloride salt capsule
GSK3640254 bis- salt · 1 trial · 1 indication
Blood samples were collected at designated timepoints. Pharmacokinetic (PK) parameters of GSK3640254 were calculated using non-compartmental methods. Geometric mean and percentage (%) geometric coefficient of variation have been presented.
Blood samples were collected at designated timepoints. PK parameters of GSK3640254 were calculated using non-compartmental methods. Geometric mean and % geometric coefficient of variation have been presented. Statistical analysis of PK parameters was done using mixed effect model for evaluation of relative bioavailability (Frel). Point estimate and 90% confidence interval (CI) for the ratio of geometric least square mean of the test mesylate salt capsule to the reference Hydrochloride capsule were calculated for AUC(0-t).
Blood samples were collected at designated timepoints. PK parameters of GSK3640254 were calculated using non-compartmental methods. Geometric mean and % geometric coefficient of variation have been presented. Statistical analysis of PK parameters was done using mixed effect model for evaluation of Frel. Point estimate and 90% CI for the ratio of geometric least square mean of the test mesylate salt capsule to the reference Hydrochloride capsule were calculated for Cmax.
Blood samples were collected at designated timepoints. PK parameters of GSK3640254 were calculated using non-compartmental methods. Median and full range of Tmax have been presented.
Blood samples were collected at designated timepoints. PK parameters of GSK3640254 were calculated using non-compartmental methods. Geometric mean and % geometric coefficient of variation have been presented.
| Arm | Type | Description |
|---|---|---|
| GSK3640254 Bis-hydrochloride followed by GSK3640254 mesylate | EXPERIMENTAL | The subjects in this arm will receive an oral administration of 200 mg, as 2 GSK3640254 bis-hydrochloride salt Capsules(reference), as single oral dose, on the morning of Day 1 during Period 1 of the study. This will be followed by an oral administration of 200 mg, as 2 GSK3640254 Mesylate salt capsule (test), as single oral dose, on the morning of Day 1, during Period 2 of the study. The drug will be administered following a moderate calorie and fat meal. There will be a minimum washout of 7 days between each dose of study treatment. |
| GSK3640254 Mesylate followed by GSK3640254 Bis-hydrochloride | EXPERIMENTAL | The subjects in this arm will receive an oral administration of 200 mg as 2 GSK3640254 Mesylate salt capsule (test), as single oral dose, on the morning of Day 1 during Period 1 of the study. This will be followed by an oral administration of 200 mg, as 2 GSK3640254 bis-hydrochloride salt Capsule, 100 mg (reference), as single oral dose, on the morning of Day 1 during Period 2, of the study. The drug, will be administered following a moderate calorie and fat meal. There will be a minimum washout of 7 days between each dose of study treatment. |
| Name | Type | Description |
|---|---|---|
| GSK3640254 bis-hydrochloride salt capsule | DRUG | Administered orally (as single dose) on morning of Day 1, as 2 capsules of 100 mg following a moderate calorie and fat meal during Period 1 and Period 2, at the specified sequence, as per study. |
| GSK3640254 Mesylate Salt Capsule | DRUG | Administered orally (as single dose) on morning of Day 1, as 2 capsules of , 100 mg following a moderate calorie and fat meal during Period 1 and Period 2, at the specified sequence, as per study. |
Inclusion Criteria: * Subject must be 18 to 55 years of age inclusive, at the time of signing the informed consent * Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * Body weight \>= 50 k...
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GSK3640254 bis- salt is an investigational small molecule developed by GSK plc for HIV infections. It is a bis-hydrochloride salt formulation of GSK3640254, supplied as a capsule. The compound has been studied in a Phase 1 clinical trial and has not been approved for any indication.
GSK3640254 bis- salt is being developed for the treatment of HIV Infections. It is an investigational agent and has not been approved for marketing. The only reported clinical study enrolled healthy adult volunteers rather than patients with HIV.
GSK3640254 bis- salt is developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK is the sponsor of the clinical program evaluating this bis-hydrochloride salt capsule formulation of GSK3640254.
GSK3640254 bis- salt is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug remains investigational and has not received FDA approval for any indication.
GSK3640254 bis- salt has been evaluated in one completed Phase 1 trial, NCT03575962, titled A Study to Compare the Relative Bioavailability of Two Different Formulations of GSK3640254. The trial enrolled 14 healthy adult volunteers in the United Kingdom and used a controlled, randomized design.
Yes. GSK3640254 bis- salt and GSK3640254 bis-hydrochloride salt capsule refer to the same investigational product. The bis-hydrochloride salt is the capsule formulation of GSK3640254 studied in the Phase 1 bioavailability trial NCT03575962.