A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Pharmacodynamic Effects of VX-150, a Highly Selective NaV1.8 Inhibitor, in Healthy Male Adults.

ABSTRACT:

Objective

To evaluate the analgesic potential, safety, tolerability, and pharmacokinetics of VX-150, a pro-drug of a highly selective NaV1.8 inhibitor, in healthy subjects.

Design

This was a randomized, double-blind, placebo-controlled, crossover study in healthy subjects.

Subjects

Twenty healthy male subjects with an age of 18-55 years, inclusive, were enrolled. Eligibility was based on general fitness, absence of current or previous medical conditions that could compromise subject safety, and a training assessment of pain tolerance across pain tests to exclude highly tolerant individuals whose tolerance could compromise the ability to detect analgesic responses. All dosed subjects completed the study.

Methods

Subjects were randomized 1:1 to one of two sequenc

SUBMITTER: Hijma HJ 

PROVIDER: S-EPMC8346919 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature