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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06480981 | Multiple Ascending Dose Noribogaine PK/PD in Healthy Volunteers | PHASE1 | COMPLETED | 55 | — | — | Jun 20, 2024 | Jan 13, 2025 | Jan 22, 2026 | 1 | United Kingdom |
Determination of maximum plasma concentration of noribogaine
Determination of maximum plasma concentration of noribogaine
Determination of the time to reach the maximum plasma concentration of noribogaine
Determination of the time to reach the maximum plasma concentration of noribogaine
Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine
Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine
Determination of the area under the plasma concentration-time curve from time 0 to infinity of noribogaine
Determination of elimination half-life (t1/2) of noribogaine
Determination of elimination half-life (t1/2) of noribogaine
| Arm | Type | Description |
|---|---|---|
| Noribogaine 20mg | EXPERIMENTAL | 1 x Noribogaine 10mg capsule twice daily |
| Noribogaine 40mg | EXPERIMENTAL | 1 x Noribogaine 20mg capsule twice daily |
| Noribogaine 60mg | EXPERIMENTAL | 1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily |
| Noribogaine 80mg | EXPERIMENTAL | 2 x Noribogaine 20mg capsule twice daily |
| Name | Type | Description |
|---|---|---|
| Noribogaine | DRUG | Noribogaine capsules |
Inclusion Criteria: * Ability to provide written, personally signed, and dated informed consent. * Healthy male and female participants between the ages of 18 to 45 inclusive. * BMI 18 - 30 kg/m2. * Non- or ex-smoker. * Normal ECG findings i.e. QTcF interval ≤ 450 ms and normal morphology that woul...