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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00931073 | A Phase I Study To Estimate The Effect Of Ketoconazole And Omeprazole On The Pharmacokinetics Of Dimebon In Healthy Subjects Who Are Normal Or Poor CYP2D6 Metabolizers | PHASE1 | COMPLETED | 24 | — | — | Jul 1, 2009 | Oct 1, 2009 | Nov 18, 2009 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Period 1 | EXPERIMENTAL | - |
| Period 2 | EXPERIMENTAL | - |
| Period 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Dimebon alone | DRUG | Pharmacokinetics of a single oral dose of 10 mg Dimebon (tablet) will be assessed in subjects with a CYP2D6 extensive and poor metabolizer status based on genotyping as screening |
| Dimebon + Ketoconazole | DRUG | Pharmacokinetics of a single oral dose of 10 mg Dimebon (tablet) will be assessed on Day 4 during the daily administration of ketoconazole (400 mg, Day 1-11) in subjects with a CYP2D6 extensive and poor metabolizer status based on genotyping as screening |
| Dimebon + Omeprazole | DRUG | Pharmacokinetics of a single oral dose of 10 mg Dimebon (tablet) will be assessed on Day 5 during the daily administration of omeprazole(40 mg, Day 1-12) in subjects with a CYP2D6 extensive and poor metabolizer status based on genotyping as screening |
Inclusion Criteria: * Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * Subjects must have either a CYP2D6 EM (n=12) or PM (n=12) status based on genotyping at screening. * Subjects must have a CYP2C19 EM status based ...