NCT06480981

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: DemeRx NB · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Noribogaine	Noribogaine capsules

Timeline

• Start date: 2024-06-20
• Primary completion: 2024-12-23
• Completion: 2025-01-13
• First posted: 2024-07-01
• Last updated: 2026-01-22
• Results posted: 2026-01-22

Locations

1 site across 1 country: United Kingdom