Pharmacodynamic Study of 100mg Suzegtrigine vs Placebo in Healthy Male Adults
NCT06972212 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-07-03
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
- 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
Sponsors & Collaborators
-
Latigo Biotherapeutics
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-06-04
- Primary Completion
- 2025-06-28
- Completion
- 2025-06-28
- FDA Drug
- Yes
Countries
- New Zealand
Study Locations
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