mavatrep (JNJ-39439335) / J&J - LARVOL DELTA

A study to investigate the safety, tolerability, and pharmacokinetics of JNJ-39439335 in healthy Japanese and Caucasian adult male participants (clinicaltrials.gov) - P1, N=86; Sponsor: Janssen Research & Development, LLC; Active, not recruiting -> Completed.

Trial completion • Pain

Bioavailability and Pharmacokinetics of TRPV1 Antagonist Mavatrep (JNJ-39439335) Tablet and Capsule Formulations in Healthy Men: Two Open-Label, Crossover, Single-Dose Phase 1 Studies. (PubMed, Clin Pharmacol Drug Dev) - "Mavatrep safety profiles were similar across formulations and under fasted and fed conditions. No new safety concerns were reported."

Clinical • Journal • P1 data • PK/PD data

Pharmacokinetics and Safety of Mavatrep (JNJ-39439335), a TRPV1 Antagonist in Healthy Japanese and Caucasian Men: A Double-Blind, Randomized, Placebo-Controlled, Sequential-Group Phase 1 Study. (PubMed, Clin Pharmacol Drug Dev) - "The most common adverse events observed were thermohypoesthesia, feeling cold, chills, and feeling hot. Mavatrep and its metabolites exhibited similar PK profiles after single ascending doses in healthy Japanese and caucasian men."

Clinical • Journal • P1 data • PK/PD data