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The purpose of this study is to select the formulation with the optimal pharmacokinetic profile for an hypnotic drug to further develop in the market.
A single-centre, open-label, randomized, single-dose, 6-way crossover study to investigate the pharmacokinetics, safety and tolerability of 6 different formulations of SB-649868 30 mg (Part A) and the effect of food on the selected formulation of SB-649868 pharmacokinetic (Part B) in healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy male subjects | Experimental | In Part A each subject will participate in six sessions and will be administered, in randomized order, single doses of five new formulations (formulation B, C, D, E and F) of SB-649868 30 milligrams (mg), in fasted state and a single dose of the original formulation (formulation A), after a standard Food and Drug Administration (FDA) High-Fat breakfast. All dosing sessions will be separated by a washout session of at least 5 ± 2 days after each dose. In Part B a single dose of the selected SB-649868 30 mg formulation will be administered after a standard FDA High-Fat breakfast. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formulation A | Drug | Formulation A represents the original formulation. SB-649868 10 mg film coated tablet (3 tablets to reach 30 mg), containing micronized drug substance. Formulation A will be administered in Part A. |
| Measure | Description | Time Frame |
|---|---|---|
| -Part A: SB-649868 levels of 6 formulation predose, 0.5, 1, 1.5, 2,3,4,5,6,8,12 and 24hours post-dose | predose, 0.5, 1, 1.5, 2,3,4,5,6,8,12 and 24hours post-dose | |
| -Part B: SB-649868 levels of selected formulation after food at the same timepoints as in Part A | predose, 0.5, 1, 1.5, 2,3,4,5,6,8,12 and 24hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| -AE, Lab values and cardiovascular monitoring throughout study participation | throughout study participation | |
| -Romberg heel-to-toe test at discharge | at discharge | |
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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 | Verona | Veneto | 37134 | Italy |
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| Label | URL |
|---|---|
| Results for study OXS105205 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 |
| C000605651 | D-Worm |
| C087325 | Granuflex E |
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| Formulation B | Drug | Formulation B will represent SB-649868 10 mg film coated tablet containing micronized drug substance (3 tablets to reach 30 mg), but contains additional surfactant. Formulation B will be administered in Part A. |
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| Formulation C | Drug | Formulation C will represent SB-649868 10 mg lipophilic capsule (3 capsules to reach 30 mg). Formulation C will be administered in Part A. |
|
| Formulation D | Drug | Formulation D will represent SB-649868 10 mg film coated tablet (3 tablets to reach 30 mg), containing nanomilled and spray dried powder. Formulation D will be administered in Part A. |
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| Formulation E | Drug | Formulation E will represent SB-649868 10 mg capsule (3 capsules to reach 30 mg), containing nanomilled and spray dried powder. Formulation E will be administered in Part A. |
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| Formulation F | Drug | Formulation F will represent SB-649868 15 mg liquid filled capsule (2 capsules to reach 30 mg). Formulation F will be administered in Part A. |
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| Formulation G | Drug | Formulation G will be the selected formulation of SB-649868 30 mg to be assessed in Part B. The formulation will be administered after a standard FDA High-Fat breakfast |
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| -Cognitive functions predose, 0.5, 1, 2, 4, 6 hours post-dose |
| predose, 0.5, 1, 2, 4, 6 hours post-dose |
| Pharmacodynamic endpoint: Bond Lader Visual Analogue Scale (VAS) score | pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Day 1 |
| D001523 |
| Mental Disorders |