Phase 1
N=55
Multiple Ascending Dose Noribogaine PK/PD in Healthy Volunteers
Pharmacokinetics
Bottom Line
View on ClinicalTrials.gov: NCT06480981 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Pharmacokinetics Cmax Day 1 — 10.4; 22.7; 39.5; 45.2 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Noribogaine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- DemeRx NB
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics Cmax Day 1 |
10.4; 22.7; 39.5; 45.2 | — |
| PRIMARY Pharmacokinetics Cmax Day 8 |
28.7; 45.5; 91.9; 113 | — |
| PRIMARY Pharmacokinetics Tmax Day 1 |
4.01; 2.75; 3.27; 3.50 | — |
| PRIMARY Pharmacokinetics Tmax Day 8 |
3.5; 1.87; 2.53; 3.0 | — |
| PRIMARY Pharmacokinetics AUC0-t Day 1 |
87.8; 196; 335; 414 | — |
| PRIMARY Pharmacokinetics AUC0-t Day 8 |
289; 429; 847; 1030 | — |
| PRIMARY Pharmacokinetics AUC0-infinity Day 8 |
934; 974; 2200; 2550 | — |
| PRIMARY Pharmacokinetics t1/2 Day 1 |
13.8; 10.5; 9.59; 11.5 | — |
| PRIMARY Pharmacokinetics t1/2 Day 8 |
23.0; 14.0; 28.4; 25.4 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06480981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.