Multiple ascending dose noribogaine PK/PD study in healthy volunteers
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled trial to evaluate multiple dose pharmacokinetics, pharmacodynamics, safety, and tolerability of ascending doses of noribogaine in healthy volunteers
IRAS ID
1009536
Contact name
Deborah Mash
Contact email
Sponsor organisation
DemeRx NB, Inc.
Eudract number
2024-000121-41
Clinicaltrials.gov Identifier
Research summary
DemeRx NB, Inc. is exploring noribogaine as a potential treatment for people struggling with alcohol use disorder. This drug shows promise based on its effects in animal studies and its known characteristics. Early studies involving healthy individuals and those struggling with opioid dependence suggest that noribogaine can be safely administered in various doses and might have long-lasting effects. These studies also found some side effects, like headaches and nausea, but no serious concerns so far. The study we are proposing within this application aims to further understand how noribogaine behaves in the body (pharmacokinetics) and its potential effect on the heart rhythm (pharmacodynamics). It will also assess its safety and tolerability. The study will involve 60 healthy volunteers who will be randomly assigned to receive either noribogaine capsules or a placebo (inactive substance) for eight days. They will stay at the research site for 13 days and return for a follow-up visit after a few days. The research physicians will carefully monitor the participants throughout the study, checking for any potential adverse events and their overall well-being. This research holds promise for developing a new treatment option for individuals struggling with alcohol use disorder.
Lay Summary:
"This study looked at the safety of repeated doses of Noribogaine, an investigational drug being developed as a possible future treatment for alcohol use disorder. Alcohol addiction is a long-term condition that affects how the brain controls behaviour and decision-making, often leading to continued drinking despite harm, and withdrawal symptoms when alcohol use stops. Before this study, Noribogaine had been tested in earlier clinical trials in healthy volunteers and in people with opioid dependence, and was well-tolerated with no serious side effects reported. These earlier findings supported further research into Noribogaine.The study aimed to find out if the drug is safe, assess how long the drug remained in the blood and how the drug affects the heart activity. The study was sponsored and funded by DemeRx NB, Inc. and carried out at Richmond Pharmacology Ltd, a specialist clinical research unit in London, UK, and was led by experienced clinical research doctors and staff. There was no formal patient or public involvement in designing the study, which is common for early-phase safety studies.
A total of 55 healthy adult participants, both men and women aged 18 to 45 years, took part in the study after giving written informed consent. Participants were randomly assigned to receive either Noribogaine capsules at increasing dose levels, or a placebo capsule containing no active medicine. The capsules were taken by mouth over an 8-day period while participants stayed in the research unit and were closely monitored.
During the study, participants had regular health checks, including blood tests, heart monitoring, and physical examinations, with a follow-up visit after treatment ended. All side effects were mild or moderate, temporary and went away on their own. No serious side effects related to Noribogaine were reported. The study showed that higher doses of Noribogaine led to higher levels of the drug in the blood in a predictable way. Transient changes in heart rhythm measurements were also observed at doses above 20 mg per day. Overall, Noribogaine was generally safe and well-tolerated in healthy participants.
Although the study did not provide direct benefit to participants, the findings provide important safety information for researchers. The results support further research, including future studies in people with alcohol use disorder to assess whether Noribogaine may be effective as a treatment. More information about this study can be obtained from the sponsor, DemeRx NB, Inc., using the study reference DMX-NB-001, and by accessing the following link: https://clinicaltrials.gov/study/NCT06480981"
REC name
London - London Bridge Research Ethics Committee
REC reference
24/LO/0131
Date of REC Opinion
17 May 2024
REC opinion
Further Information Favourable Opinion