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CompletedPhase 1Results posted

Multiple Ascending Dose Noribogaine PK/PD in Healthy Volunteers

NCT06480981 · DemeRx NB

Closed to entry
Status
Not accepting participants
Phase 1
Phase
55
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Pharmacokinetics Cmax Day 1

    Measured over Day 1

  • Pharmacokinetics Cmax Day 8

    Measured over Day 8

  • Pharmacokinetics Tmax Day 1

    Measured over Day 1

  • Pharmacokinetics Tmax Day 8

    Measured over Day 8

  • Pharmacokinetics AUC0-t Day 1

    Measured over Day 1

  • Pharmacokinetics AUC0-t Day 8

    Measured over Day 8

  • Pharmacokinetics AUC0-infinity Day 8

    Measured over Day 8

  • Pharmacokinetics t1/2 Day 1

    Measured over Day 1

  • Pharmacokinetics t1/2 Day 8

    Measured over Day 8

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 45 Years
Ages
All
Sex
Accepted
Healthy volunteers
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.

Where

1 study site

FacilityCityRegionCountry
Richmond PharmacologyLondonUnited Kingdom

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06480981 on ClinicalTrials.gov →

Last updated in the registry 2026-01-22. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance