Multiple Ascending Dose Noribogaine PK/PD in Healthy Volunteers
This Phase I, randomised, triple-masked, placebo-controlled sequential dose-escalation trial (n=55) studied repeated oral noribogaine in healthy adults. Participants were enrolled across four ascending-dose cohorts corresponding to total daily noribogaine doses of 20 mg, 40 mg, 60 mg or 80 mg, with the study designed to assess safety, tolerability, pharmacokinetics and pharmacodynamics. Noribogaine capsules were taken twice daily. The primary pharmacokinetic outcomes included maximum plasma concentration, time to maximum concentration, area under the concentration-time curve and elimination half-life, assessed on Days 1 and 8. The study also monitored adverse events and other safety measures during the multiple-dose period.
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Detailed Description
This trial will be a randomised, double-blind, sequential-group, multiple-dose, placebo-controlled, dose escalation trial to characterise the pharmacokinetics (PK), pharmacodynamics (PD) and safety of noribogaine in healthy adult participants.
Study Arms & Interventions
Ibogaine 10 mg
experimental1 x Noribogaine 10mg capsule twice daily
Interventions
- Ibogaine10 mgvia Oral• twice daily
Noribogaine; represented under Blossom’s Ibogaine compound record.
Ibogaine 20 mg
experimental1 x Noribogaine 20mg capsule twice daily
Interventions
- Ibogaine20 mgvia Oral• twice daily
Noribogaine; represented under Blossom’s Ibogaine compound record.
Ibogaine 30 mg
experimental1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily
Interventions
- Ibogaine30 mgvia Oral• twice daily
Noribogaine; represented under Blossom’s Ibogaine compound record.
Ibogaine 40 mg
experimental2 x Noribogaine 20mg capsule twice daily
Interventions
- Ibogaine40 mgvia Oral• twice daily
Noribogaine; represented under Blossom’s Ibogaine compound record.
Participants
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 would permit accurate assessment of the QT interval.
- Participants must agree to use highly
Exclusion Criteria
- History of, or concurrent clinically significant cardiovascular, dysautonomia, gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic or psychiatric, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study.
- Family history in first degree relatives for unknown and/or known arrhythmia-related cardiac events, cardiomyopathy, syncope, long QT syndrome, Brugada's syndrome, sudden death attributed to cardiac causes, and familial cardiac channelopathies.
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with interpretation of QTc interval changes.
- Previous or current alcohol, or other drug dependence.
Study Protocol, Arms & Participants
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Locations
Recent activity
- CompletedMultiple Ascending Dose Noribogaine PK/PD in Healthy Volunteers (NCT06480981, ibogaine)
- StartedMultiple Ascending Dose Noribogaine PK/PD in Healthy Volunteers (NCT06480981, ibogaine)
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