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Clinical Pharmacology in Drug Development

ISSN 2160-763X

3 papers in the library · 110 citations · publishing 2015-2020

Papers

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Exposure‐Response Analysis to Assess the Concentration‐QTc Relationship of Psilocybin/Psilocin

Clinical Pharmacology in Drug Development April 6, 2020 Elyes Dahmane, Paul R. Hutson, Jogarao Gobburu 44 citations

Abstract Psilocybin is being developed for treating major depressive disorder. Psilocybin is readily dephosphorylated to psilocin upon absorption. The potential for psilocin proarrhythmic effect was assessed using a concentration‐QTc interval (C‐QTc) analysis from an open‐label single ascending dose study of psilocybin. Psilocybin doses ranged from 0.3 to 0.6 mg/kg. This trial showed a...

DOI: 10.1002/cpdd.796 (opens in new tab) Psilocybin Hallucinogen Pharmacology Qt interval +2

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

Clinical Pharmacology in Drug Development November 1, 2016 Paul Glue, Gavin Cape, Donna Tunnicliff et al. 66 citations

Ibogaine is a psychoactive substance that may reduce opioid withdrawal symptoms. This was the first clinical trial of noribogaine, ibogaine's active metabolite, in patients established on methadone opioid substitution therapy (OST). In this randomized, double-blind, placebo-controlled single ascending-dose study, we evaluated the safety, tolerability, and pharmacokinetics of noribogaine in 27...

The expanding utility of microdosing

Clinical Pharmacology in Drug Development November 1, 2015 Graham Lappin

AbstractThe concept of microdosing has been around for more than a decade. It consists of the subpharmacologic administration of an investigational drug (1% of the pharmacologic dose or 100 µg, whichever is lower) to human subjects to attain pre–phase 1 pharmacokinetics (PK) in humans. The major concern with microdosing has been the potential for nonlinear PK between doses, but methods are...