Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01036061 | GSK618334 Repeat Dose Study | PHASE1 | COMPLETED | 46 | — | — | Sep 28, 2009 | Feb 17, 2010 | Jun 22, 2017 | 1 | United Kingdom |
| NCT00814957 | An Open Label Positron Emission Tomography (PET) Study of GSK618334 in Healthy Male Subjects Using 11C-PHNO as PET Ligand | PHASE1 | COMPLETED | 12 | — | — | Dec 8, 2008 | Jun 11, 2009 | Jul 7, 2017 | 1 | United Kingdom |
| NCT00513279 | To Investigate If Single Doses Of GSK618334 Are Safe And To Investigate Blood Levels Of GSK618334 | PHASE1 | COMPLETED | 20 | — | — | Jun 28, 2007 | Oct 4, 2007 | Sep 15, 2017 | 1 | United Kingdom |
| 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...