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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06194864 | Drug Interaction Study | PHASE1 | COMPLETED | 45 | — | — | Jan 18, 2024 | May 22, 2024 | Sep 19, 2024 | 1 | Canada |
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis
| Arm | Type | Description |
|---|---|---|
| Part 1 | EXPERIMENTAL | ecopipam 89.6 mg on Days 1 and 9 with repeat doses of itraconazole Days 6-16. |
| Part 2 | EXPERIMENTAL | ecopipam 179.2 mg on Days 1 and 13 with repeat doses of rifampicin days 6-20. |
| Name | Type | Description |
|---|---|---|
| Itraconazole | DRUG | itraconazole 200 mg QD Days 6 to 16 |
| rifampicin | DRUG | rifampicin 600 mg QD Days 6 to 20 |
| Ecopipam | DRUG | 89.6 mg on Days 1 and 9 for Part 1 or 179.2 mg on Days 1 and 13 for Part 2 |
Inclusion Criteria: * Male subjects or femail subjects of non-childbearing potential * ≥18 and ≤55 years of age * BMI \>18.5 and \<30.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females. * Subjects must be healthy, as determined by the Investigator, based on medical history, physica...