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The purpose of this study is to define the absorption, breakdown and excretion of a single dose of radiolabelled SB-649868 and its breakdown products by measuring their concentration in blood, urine and faeces over a 7-10 day period. "Radiolabelled" means that the test drug has a radioactive component to help us track the drug. The safety and tolerability of the test drug will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy male subjects | Experimental | Each subject will receive a single oral dose of 14C-SB649868 (containing approximately 70 microcuries of radiocarbon and 30 milligrams of SB649868). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14C-SB649868 | Drug | SB-649868 will be provided as powder in a bottle which will be reconstituted into a solution prior to dosing via a hard gelatin capsule. Each subject will receive one unit dose of SB-649868 30 milligram reconstituted powder presented in a size 00 capsule once. The capsule will be swallowed with 160 milliliters of water. |
| Measure | Description | Time Frame |
|---|---|---|
| Excretion of SB649868 by measuring radioactivity in urine and faeces | over 7-10 days. | |
| Plasma levels of SB-649868 by measuring drug levels and radioactivity in plasma. Plasma, urine,faeces samples to study the metabolites of SB649868. | over 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of 14C-SB649868 by adverse event monitoring, lab samples and cardiovascular monitoring. | over the course of the study |
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Inclusion criteria:
LH, FSH and testosterone hormones must be within normal reference range.
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 | Tranent | West Lothian | EH33 2NE | United Kingdom |
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| Label | URL |
|---|---|
| Results for study 109139 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C557781 | N-((1-((5-(4-fluorophenyl)-2-methyl-4-thiazolyl)carbonyl)-2-piperidinyl)methyl)-4-benzofurancarboxamide |
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|
| D001523 |
| Mental Disorders |