Ascending Single-Dose, Double-Blind, Placebo-Controlled Safety Study of Noribogaine in Opioid-Dependent Patients

Glue, Paul, Cape, Gavin, Tunnicliff, Donna, Lockhart, Michelle, Lam, Fred, Hung, Noelyn, Hung, C. Tak, Harland, Sarah, Devane, Jane, Crockett, R. S., Howes, John, Darpo, Borje, Zhou, Meijian, Weis, Holger, Friedhoff, Lawrence · 2016 · Clinical Pharmacology in Drug Development

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First-in-patient RCT of noribogaine (60-180mg) in 27 opioid-dependent patients. Concentration-dependent QTcI prolongation (0.17 ms/ng/mL); mean ΔΔQTcI 16/28/42 ms at 60/120/180mg. t½ 24-30h, dose-linear PK.

Dosing: 60–180 mg single oral dose (oral)

Sample size: 27

Safety data present: QTC

Contraindications: Pre-existing QTc prolongation, Concurrent QT-prolonging medications, Risk factors for torsades de pointes