Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Learnings from a Double-Blind, Randomized, Placebo-Controlled, Sequential Group First-in-Human Study of the TRPV1 Antagonist, JNJ-38893777, in Healthy Men

Background and Objective Nociceptive and neuropathic pain, one of common reasons of disability and loss of quality life, are often undertreated due to safety concerns with current therapies. This study assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of JNJ-38893777, a potent...

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Bibliographic Details
Published in:Clinical drug investigation 2015-06, Vol.35 (6), p.353-363
Main Authors: Manitpisitkul, Prasarn, Mayorga, Arthur, Shalayda, Kevin, De Meulder, Marc, Romano, Gary, Jun, Chen, Moyer, John A.
Format: Article
Language:English
Subjects:
Adolescent
Adult
Area Under Curve
Azepines - administration & dosage
Azepines - adverse effects
Azepines - pharmacokinetics
Chemistry, Pharmaceutical
Double-Blind Method
Humans
Internal Medicine
Male
Medicine
Medicine & Public Health
Middle Aged
Original Research Article
Pharmacology/Toxicology
Pharmacotherapy
Piperidines - administration & dosage
Piperidines - adverse effects
Piperidines - pharmacokinetics
Tablets
Tandem Mass Spectrometry
TRPV Cation Channels - antagonists & inhibitors
Young Adult
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Summary:Background and Objective Nociceptive and neuropathic pain, one of common reasons of disability and loss of quality life, are often undertreated due to safety concerns with current therapies. This study assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of JNJ-38893777, a potent and selective transient receptor potential vanilloid 1 (TRPV1) channel antagonist in healthy men. Methods In a single-center, double-blind, placebo-controlled, sequential group, single-ascending-dose phase 1 study, 80 healthy men (18–45 years old; body mass index 18.5 to
ISSN:1173-2563
1179-1918
DOI:10.1007/s40261-015-0285-7