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Study to compare PK of a new 120mg tablet with two 60mg tablets. This is required because we plan to have only single tablets administered in the later phase clinical trials but we have not had a 120mg strength before. As this is a new previously untested strength we need to ensure that the PK is similar to that achieved using 2x60mg before we start a large manufacturing campaign and before we administer to a large number of patients. The study is planned to consist of a single part, with two dosing periods, periods 1 and 2 consisting of 18 subjects. There will be 20 days washout between each dose. Initially 4 subjects will be given a single oral dose of 120 mg SB-773812 and 2 will be given placebo. If 120mg SB-773812 is well tolerated in the first four volunteers, the remaining 12 subjects will be dosed. If the 120mg single oral dose in the first 4 subjects is poorly tolerated, the study will be stopped. Subjects will return to the centre for follow-up 14 to 21 days after the final dose.It is expected that the total duration of the study should be approximately 11 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects in treatment sequence AB | Experimental | In treatment sequence AB first subjects will be randomized to receive treatment A (two tablets of 60 milligram [mg] of SB-773812) and one placebo tablet. Then subjects will receive treatment B (one tablet of 120 mg of SB-773812) and two placebo tablets . There will be a wash-out period of 20 days between. |
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| Subjects in treatment sequence BA | Experimental | In treatment sequence BA first subjects will be randomized to receive treatment B (one tablet of 120 mg of SB-773812) and two placebo tablets. Then subjects will receive treatment A (two tablets of 60 mg of SB-773812) and one placebo tablet. There will be a wash-out period of 20 days between. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB- 773812 60 mg | Drug | SB- 773812 will be available dose strength of 60 mg and administered orally by subjects. |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood sampling over a period 336 hrs post SB773812 dosing in both dosing sessions. | 336 hrs post SB773812 dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: ECG, vital signs, clinical labs over 336 hours post SB-773812 dosing in both dosing sessions. | 336 hours post SB-773812 dosing | |
| Continuous adverse event monitoring from dosing until study conclusion and follow up, 7-14days after last dose. | 7-14days after last 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 NAA105737 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| SB- 773812 120 mg | Drug | SB- 773812 will be available dose strength of 120 mg and administered orally by subjects. |
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| Placebo | Drug | Placebo tablets will be administered orally by subjects. |
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