Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Noribogaine · 1 trial · 1 indication
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...
Noribogaine is an investigational small molecule being developed by AtaiBeckley Inc. (ATAI). It is currently in Phase 1 clinical development for pharmacokinetics, meaning it is being studied to understand how the drug is absorbed, distributed, metabolized, and excreted in the body. It is not yet approved and remains in clinical trials.
Noribogaine is being studied for pharmacokinetics, which is the assessment of how the drug moves through the body. This is an early-stage investigation in healthy volunteers to evaluate the drug's safety and how it is processed. It is not approved for any specific disease or condition.
Noribogaine is being developed by AtaiBeckley Inc., a biopharmaceutical company traded under the ticker symbol ATAI. The company is conducting clinical trials to evaluate the drug's pharmacokinetics in healthy volunteers.
Noribogaine is in Phase 1 clinical development. A Phase 1 trial has been completed, which studied multiple ascending doses of the drug in healthy volunteers to assess its pharmacokinetics and pharmacodynamics. The drug is investigational and has not been approved by regulatory authorities.
Noribogaine has one completed Phase 1 clinical trial registered as NCT06480981, titled "Multiple Ascending Dose Noribogaine PK/PD in Healthy Volunteers." This trial enrolled 55 participants in the United Kingdom and was a randomized, double-blind, controlled study involving healthy volunteers aged 18 years and older.
Noribogaine is a distinct compound from ibogaine, though it is related. While ibogaine is a naturally occurring psychoactive substance, noribogaine is a separate small molecule being developed by AtaiBeckley Inc. for its pharmacokinetic properties. The two are not the same drug.