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A single blind, randomized, placebo-controlled, crossover study in twenty four healthy male subjects. Subjects will be divided into two cohorts with alternate panel design. The study is investigating the safety, tolerability and pharmacokinetics of single oral escalating doses of GSK586529.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving treatment in cohort 1 | Experimental | Subjects will receive one of the following sequences; ABDF,BADF, BDAF or BDFA (A=Placebo, B= GSK586529 dose 1 (3 milligrams), D = GSK586529 dose 3, F = GSK586529 dose 5). |
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| Subjects receiving treatment in cohort 2 | Experimental | Subjects will receive one of the following sequences; ACEG,CAEG, CEAG or CEGA (A = Placebo, C= GSK586529 dose 2, E = GSK586529 dose 4, G = GSK586529 dose 6) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK586529 capsules | Drug | GSK586529 will be provided as white gelatin capsule with a dose of 3 milligrams. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Blood levels of GSK586529 to determine pharmacokinetic parameters | Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose | |
| Urinary recovery of GSK586529 | Pre-dose, 0-6, 6-12, 12-24, 24-48, 48-72 and 72-96 hours post-dose |
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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 | London | NW10 7NS | United Kingdom |
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| Label | URL |
|---|---|
| Results for study CRZ107432 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| GSK586529 tablets | Drug | GSK586529 will be provided as a yellow film-coated tablets for oral administration at three different strengths 10 milligrams, 60 milligrams and 120 milligrams. |
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| Placebo | Drug | Placebo tablets and capsules will be provided to subjects. |
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