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Subjects will be screened within 28 days, Simvastatin dose and single SB-649868 dose 10 and 7 days prior to repeat dosing respectively, 15 days SB-649868 repeat dosing with safety and cognition function tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Subjects in Cohort 1 will be randomized to receive 5 milligram (mg) of SB-649868 or Placebo along with 10 mg of simvastatin. |
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| Cohort 2 | Experimental | Subjects in Cohort 2 will be randomized to receive two or three times higher than the starting dose of SB-649868 or Placebo along with 10 mg of simvastatin. |
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| Cohort 3 | Experimental | Subjects in Cohort 3 will be randomized to dose higher than that administered in Cohort 2 of SB-649868 or Placebo along with 10 mg of simvastatin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB-649868 | Drug | Subjects will receive SB-649868 5 mg, 25 mg tablets orally 1 hour prior to simvastatin administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| -AE, Lab values and cardiovascular monitoring after the SD and 14 days RD period (15 days) | after the SD and 14 days RD period (15 days) | |
| - SB649868 levels on days -7, 1, 4, 7 and 14 (pre-dose and post-dose) | on days -7, 1, 4, 7 and 14 (pre-dose and post-dose) | |
| - Simvastatine and Beta-idroxy-simvastatine levels on days -10,1,4,7 and 15 | on days -10,1,4,7 and 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive functions, sleep profile and appetite assessment on days -7, 7 and 14. | on days -7, 7 and 14. |
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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 | Berlin | 14050 | Germany |
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| Label | URL |
|---|---|
| Results for study OXS104092 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| 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 |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo | Drug | Subjects will receive matching placebo tablets to SB-649868 orally 1 hour prior to simvastatin administration. |
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| Simvastatin | Drug | Subjects will receive Simvastatin 10 mg tablets orally. |
|
| D001523 |
| Mental Disorders |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |