Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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) ...
SB773812 is an investigational small molecule being developed for the treatment of schizophrenia. It is a psychiatry drug candidate that has been studied in clinical trials involving patients with schizophrenia, as well as in healthy volunteer studies.
SB773812 is being developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker symbol GSK. The company has conducted clinical trials to evaluate the drug's effects in schizophrenia.
SB773812 is in Phase 2 clinical development for schizophrenia. It has completed five clinical trials, including Phase 1 studies, with a total enrollment of 547 participants. The drug remains investigational and has not been approved by regulatory authorities.
SB773812 has completed five clinical trials, including NCT00197093, an in-patient study in schizophrenic patients; NCT00269035, a SPECT study in schizophrenic patients; NCT00411866, a drug interaction study with ketoconazole; and NCT00500201, a bioavailability study of two tablet forms.
SB773812 is also known by the name SB-773812, as seen in the clinical trial titles. This alternative name refers to the same investigational drug being developed by GSK plc for the treatment of schizophrenia.