NCT06480981

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2024

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

June 20, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2025

Completed
1 year until next milestone

Results Posted

Study results publicly available

January 22, 2026

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

June 19, 2024

Results QC Date

January 5, 2026

Last Update Submit

January 5, 2026

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (9)

  • 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

Study Arms (4)

Noribogaine 20mg

EXPERIMENTAL

1 x Noribogaine 10mg capsule twice daily

Drug: Noribogaine

Noribogaine 40mg

EXPERIMENTAL

1 x Noribogaine 20mg capsule twice daily

Drug: Noribogaine

Noribogaine 60mg

EXPERIMENTAL

1 x Noribogaine 10mg capsule and 1 x Noribogaine 20mg capsule twice daily

Drug: Noribogaine

Noribogaine 80mg

EXPERIMENTAL

2 x Noribogaine 20mg capsule twice daily

Drug: Noribogaine

Interventions

NoribogaineDRUG

Noribogaine capsules

Noribogaine 20mgNoribogaine 40mgNoribogaine 60mgNoribogaine 80mg

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richmond Pharmacology

London, United Kingdom

Location

MeSH Terms

Interventions

noribogaine

Results Point of Contact

Title
Principal Investigator
Organization
Richmond Pharmacology
info@richmondpharmacology.com
020 7042 5800

Study Officials

  • Jorg Taubel

    Richmond Pharmacology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2024

First Posted

July 1, 2024

Study Start

June 20, 2024

Primary Completion

December 23, 2024

Study Completion

January 13, 2025

Last Updated

January 22, 2026

Results First Posted

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)