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Also known as Ketoconazole, Olanzapine
SB773812 · 5 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Subjects receiving ketoconazole for 8 days | EXPERIMENTAL | In Session 1, subjects will receive a single oral dose of SB-773812 20 milligrams (mg), followed by 21 days-washout. In Session 2, subjects will receive once daily oral dose of ketoconazole 400 mg repeated for 8 days. On day 5, single oral dose of SB-773812 20 mg will be dosed concomitantly with ketoconazole. |
| Subjects receiving ketoconazole for 14 days | EXPERIMENTAL | In Session 1, subjects will receive a single oral dose of SB-773812 (20mg), followed by 21 days-washout. In Session 2, subjects will receive once daily oral dose of ketoconazole 400 mg repeated for 12 days. On day 5, single oral dose of SB-773812 20 mg will be dosed concomitantly with ketoconazole. |
| Treatment Group 1 | EXPERIMENTAL | Subjects in group 1 will receive SB-773812 tablet once daily till still steady Cp |
| Treatment Group 2 | EXPERIMENTAL | Subjects in group 2 will receive SB-773812 tablets once daily over 6 weeks. Risperidone tablets 6 mg once daily from Days 1-7 two tablets of 3 mg and days 8 until stable Cp 6 mg tablets |
| Name | Type | Description |
|---|---|---|
| SB-773812 | DRUG | - |
| Olanzapine | DRUG | - |
| SB- 773812 60 mg | DRUG | SB- 773812 will be available dose strength of 60 mg and administered orally by subjects. |
| SB- 773812 120 mg | DRUG | SB- 773812 will be available dose strength of 120 mg and administered orally by subjects. |
| Placebo | DRUG | Placebo tablets will be administered orally by subjects. |
| SB773812 | DRUG | SB-773812 20 mg will be available as white round film coated tablets. |
| Ketoconazole | DRUG | Ketoconazole will be available as 200mg tablets. |
| Risperidone | DRUG | Risperidone tablets will be available with dose strength of 3 and 6 mg |
Inclusion Criteria: * Meets the diagnostic criteria for schizophrenia as defined in DSM-IV. * PANSS total score of at least 70 at Screen and Baseline and a minimum score of 4 (moderate) on at least 2 of the following: conceptual disorganization (P2) hallucinatory behaviour (P3) suspiciousness (P6) ...
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SB773812 is an investigational small molecule developed by GSK plc (ticker GSK) for the treatment of schizophrenia. It has been studied in Phase 1 and Phase 2 clinical trials, and all five of its registered trials are completed. It is not described as approved, so it remains an investigational agent in clinical development.
SB773812 was studied as a treatment for schizophrenia in adults. Its clinical program includes a Phase 2 trial in adults with schizophrenia and Phase 1 studies conducted in healthy volunteers and in patients with schizophrenia. The trials enrolled adults aged 18 years and older.
SB773812 is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical trial program for the compound, including Phase 1 studies in the United Kingdom and Spain and a Phase 2 study run across the United States, Belgium, Costa Rica, Czechia, India, Peru, and Russia.
SB773812 reached Phase 2 clinical development for schizophrenia. All five of its registered trials are completed, and no trials are currently active. The Phase 2 study, NCT00259870, enrolled 338 adults with schizophrenia, while the remaining four trials were Phase 1 studies.
Five completed trials have studied SB773812. These include NCT00500201, a healthy volunteer bioavailability study; NCT00411866, a ketoconazole drug interaction study; NCT00269035, a SPECT study in patients with schizophrenia; and NCT00259870, a Phase 2 trial in adults with schizophrenia. Total enrollment across the program was 547 participants.
Yes. SB773812, SB-773812, and SB-773812 60 mg refer to the same investigational compound developed by GSK for schizophrenia. The variations reflect different formatting and dose descriptions used in study records rather than separate drugs.