Multiple Ascending Dose Noribogaine PK/PD in Healthy Volunteers

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: Noribogaine

• Registration Number: NCT06480981
• Lead Sponsor: DemeRx NB

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-19
• Study Start: 2024-06-20
• Study First Submitted QC: 2024-06-25
• Study First Posted: 2024-07-01
• Primary Completion: 2024-12-23
• Status Verified: 2025-01
• Study Completion: 2025-01-13
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Noribogaine 80mg	Noribogaine	2 x Noribogaine 20mg capsule twice daily
Noribogaine 20mg	Noribogaine	1 x Noribogaine 10mg capsule twice daily
Noribogaine 40mg	Noribogaine	1 x Noribogaine 20mg capsule twice daily
Noribogaine 60mg	Noribogaine	1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics Tmax	Day 1 to Day 8	Determination of the time to reach the maximum plasma concentration of noribogaine
Pharmacokinetics AUC0-infinity	Day 1 to Day 8	Determination of the area under the plasma concentration-time curve from time 0 to infinity of noribogaine
Pharmacokinetics Cmax	Day 1 to Day 8	Determination of maximum plasma concentration of noribogaine
Pharmacokinetics AUC0-t	Day 1 to Day 8	Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine
Pharmacokinetics t1/2	Day 1 to Day 8	Determination of elimination half-life (t1/2) of noribogaine

Trial Locations

Locations (1)

Richmond Pharmacology; 🇬🇧 London, United Kingdom