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GSK618334 is being developed as an innovative treatment for substance dependence and potentially other compulsive behavioral disorders. This study will evaluate the safety, tolerability and pharmacokinetics of single doses of GSK618334 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK618334 | Drug | GSK618334 will be available as white to off-white coated tablets. GSK618334 will be swallowed with 250 milliliters (mL) of water. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety measures: ECG, Vital Signs, Adverse Events | for 48 hours after dosing. | |
| PK measures: Blood sampling for GSK598809 | for up to 96hr post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Tests on cognition (thinking) | for 48 hours after dosing | |
| Movement rating scales | pre-dose, 2, 4 and 24 hours post-dose on Day 1 | |
| Prolactin, TSH and GH |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Harrow | Middlesex | HA13UJ | United Kingdom |
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| Label | URL |
|---|---|
| Results for study DBU107640 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| 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. |
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| pre-dose, 1, 2, 4, 8 and 24 hours post-dose on Day 1 |
| Psychological assessments | pre-dose, up to 48 hours post-dose |
| Cognitive/Impulsivity tests | pre-dose, 2, 7 and 24 hours post-dose on Day 1 |