Multiple Ascending Dose Noribogaine PK/PD in Healthy Volunteers

A Randomized, Double-blind, Placebo-controlled Trial to Evaluate Multiple Dose Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Ascending Doses of Noribogaine in Healthy Volunteers.

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 Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: Noribogaine

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Richmond Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Noribogaine 20mg; 1 x Noribogaine 10mg capsule twice daily	Drug: Noribogaine; Noribogaine capsules
Experimental: Noribogaine 40mg; 1 x Noribogaine 20mg capsule twice daily	Drug: Noribogaine; Noribogaine capsules
Experimental: Noribogaine 60mg; 1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily	Drug: Noribogaine; Noribogaine capsules
Experimental: Noribogaine 80mg; 2 x Noribogaine 20mg capsule twice daily	Drug: Noribogaine; Noribogaine capsules

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: DemeRx NB
• Investigators: Principal Investigator: Jorg Taubel, Richmond Pharmacology

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2024
• Primary Completion (Actual): December 23, 2024
• Study Completion (Actual): January 13, 2025

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: noribogaine
• Other Study ID Numbers: DMX-NB-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No