Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00259870 | SB-773812 Administered In Adults With Schizophrenia | PHASE2 | COMPLETED | 338 | — | — | Sep 1, 2005 | Aug 1, 2007 | Mar 23, 2017 | 45 | United States, Belgium +5 |
| NCT00500201 | A Healthy Volunteer Study to Assess the Relative Bioavailability of 2 Forms of SB773812 Tablets. | PHASE1 | COMPLETED | 18 | — | — | May 24, 2007 | Jul 25, 2007 | Aug 8, 2017 | 1 | United Kingdom |
| NCT00411866 | Effects Of The Drug Ketoconazole On How The Body Handles The Drug SB773812 | PHASE1 | COMPLETED | 36 | — | — | Oct 13, 2006 | Oct 10, 2007 | Aug 3, 2017 | 1 | United Kingdom |
| NCT00269035 | SPECT Study With SB-773812 In Schizophrenic Patients | PHASE1 | COMPLETED | 95 | — | — | Jun 21, 2005 | May 26, 2007 | Aug 17, 2017 | 6 | Spain |
| NCT00197093 | In-Patient Study In Schizophrenic Patients | PHASE1 | COMPLETED | 60 | — | — | Sep 1, 2004 | - | May 18, 2009 | - | — |
| 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) ...