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Also known as GSK618334 Low Dose
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 being studied for substance dependence, a psychiatric condition. It is a small molecule developed by GSK plc and has been tested in Phase 1 clinical trials conducted in the United Kingdom. All three of its recorded trials enrolled healthy volunteers rather than patients in treatment.
GSK618334 is developed by GSK plc, which trades under the ticker GSK. The company sponsored all three Phase 1 trials of the compound, which were run in the United Kingdom. GSK618334 is also referred to as GSK618334 Low Dose.
GSK618334 is in Phase 1 clinical development. All three of its registered trials are Phase 1 studies, and all three are listed as completed. There are no active trials of GSK618334 at this time, and the compound is investigational rather than approved.
GSK618334 has been studied in three completed Phase 1 trials: NCT01036061, a repeat dose study with 46 participants; NCT00814957, an open label PET study using 11C-PHNO as ligand with 12 healthy male subjects; and NCT00513279, a single dose safety and blood level study with 20 male participants. All were run in the United Kingdom.
Yes, GSK618334 Low Dose is an alternative name for GSK618334. Both names refer to the same small molecule developed by GSK plc for substance dependence. Searches using either name point to the same Phase 1 program, which includes three completed trials in the United Kingdom.
The three completed Phase 1 trials of GSK618334 enrolled a total of 78 participants. NCT01036061 enrolled 46, NCT00513279 enrolled 20, and NCT00814957 enrolled 12. The studies were randomized, double blind, and controlled, and they enrolled healthy volunteers rather than patients.