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.
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