NCT06972212

Pharmacodynamic Study of 100mg Suzegtrigine vs Placebo in Healthy Male Adults

A Randomized, Double-Blind, Placebo-Controlled Crossover Study to Evaluate the Pharmacodynamic Effects of Suzetrigine in Healthy Male Adults

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Latigo Biotherapeutics · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled within-participant crossover study in healthy male participants 18-55 years of age to assess pain tolerance during a cold pressor test. The study will be conducted at a single center in New Zealand.

Conditions

• Pain Detection
• Pain Threshold

Interventions

Type	Name	Description
DRUG	suzetrigine 100mg	Suzetrigine is an inhibitor of the NaV1.8 voltage-gated sodium channel and FDA approved for the treatment of moderate-to-severe acute pain in adults
OTHER	Placebo	biologically inactive placebo comparator

Timeline

• Start date: 2025-06-04
• Primary completion: 2025-06-28
• Completion: 2025-06-28
• First posted: 2025-05-14
• Last updated: 2025-07-03

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated drug study