Ascending-dose study of noribogaine in healthy volunteers: pharmacokinetics, pharmacodynamics, safety, and tolerability.
Journal of clinical pharmacology February 1, 2015 Paul Glue, Michelle Lockhart, Fred Lam et al. 61 citations
Noribogaine, the active metabolite of ibogaine, may help suppress withdrawal symptoms in opioid-dependent people. In a Phase I ascending single-dose, placebo-controlled, randomized, double-blind, parallel-group study in 36 healthy drug-free male volunteers, oral doses of 3, 10, 30, or 60 mg were given. Noribogaine was rapidly absorbed, reaching peak concentrations 2-3 hours after dosing, and showed dose-linear increases in exposure between 3 and 60 mg. The drug was slowly eliminated, with mean half-lives of 28-49 hours and a high volume of distribution (mean 1417-3086 L). No safety or tolerability issues were identified, and no mu-opioid agonist effects were observed in pupillometry or cold-pressor testing. Single oral doses of 3-60 mg were safe and well tolerated.