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GSK618334 · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| GSK618334 low Dose | EXPERIMENTAL | GSK618334 Low Dose |
| GSK618334 Medium Dose | EXPERIMENTAL | GSK618334 medium dose arm |
| GSK618334 High Dose | EXPERIMENTAL | GSK618334 High Dose Arm |
| GSK618334 Placebo | EXPERIMENTAL | Placebo for all 3 dose levels |
| Open-label | EXPERIMENTAL | D3 receptor antagonist |
| Cohort 1 | EXPERIMENTAL | Subjects in Cohort 1 will be randomized to one of the following sequences: ABDFH, BADFH, BDAFH, BDFAH and BDFHA in a 1:1:1:1:1 ratio where A = Placebo, B= GSK618334 dose 1 (2.5 mg), D = GSK618334 dose 3, F = GSK618334 dose 5, H = GSK618334 dose 7. On day 1, subjects will be administered a starting dose of 2.5 milligrams (mg) GSK618334. The planned doses of GSK618334 to be administered in Cohort 1 are 2.5, 25, 100 and 400mg. In each dosing period 2 subjects will receive placebo and 8 subjects will receive GSK618334. Subjects within a cohort will have a washout period of at least two weeks from last dose before receiving another dose. |
| Cohort 2 | EXPERIMENTAL | Subjects in Cohort 2 will be randomized to one of the following sequences: ACEGI, CAEGI, CEAGI, CEGAI, CEGIA in a 1:1:1:1:1 ratio where A = Placebo, C= GSK618334 dose 2, E = GSK618334dose 4, G = GSK618334 dose 6, I= GSK618334 dose 8. In each dosing period 2 subjects will receive placebo and 8 subjects will receive GSK618334. Subjects within a cohort will have a washout period of at least two weeks from last dose before receiving another dose. |
| Name | Type | Description |
|---|---|---|
| GSK618334 Low Dose | DRUG | GSK618334 low dose |
| GSK618334 PET subjects | DRUG | PET subjects |
| GSK618334 Medium Dose | DRUG | Medium Dose |
| GSK618334 High Dose | DRUG | GSK618334 High Dose |
| GSK618334 | DRUG | D3 receptor antagonist |
| GSK618334 matching placebo tablets | DRUG | GSK618334 placebo tablets visually match the active GSK618334 tablets and contain the same excipients except for the omission of the active ingredient. GSK618334 matching placebo will be swallowed with 250 mL of water. |
Inclusion Criteria: * Healthy Males and Females between the ages of 18-50 years old * Male and Female subjects must agree to use protocol specified contraceptive methods. * Male subjects only in PET parts of the study. * Capable of providing written informed consent. Exclusion Criteria: * A posit...
GSK618334 is an investigational small molecule being developed for substance dependence. It is in Phase 1 clinical development, with studies conducted in healthy volunteers to assess safety, tolerability, and blood levels. The drug is not approved and remains under investigation.
GSK618334 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company has sponsored Phase 1 clinical trials of the drug in the United Kingdom.
GSK618334 is in Phase 1 clinical development. Three Phase 1 trials have been completed, with a total enrollment of 78 participants. The drug is investigational and has not been approved for any use.
GSK618334 has completed three Phase 1 trials: NCT00513279, a single-dose safety and blood level study in 20 healthy male subjects; NCT00814957, a PET imaging study in 12 healthy male subjects; and NCT01036061, a repeat-dose study in 46 subjects. All trials were conducted in the United Kingdom.
GSK618334 is a small molecule being studied for substance dependence. Its specific molecular target has not been disclosed in the clinical trial information. The drug's mechanism of action is not described in the available data.