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Pharmacodynamic Study of 300mg Pregabalin vs Placebo in Healthy Male Adults

NCT06600607 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-05-04

No results posted yet for this study

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

pregabalin 300 mg

pregabalin is an FDA-approved anticonvulsant medication commonly used to treat nerve pain

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
2024-10-07
Primary Completion
2024-10-27
Completion
2024-10-27
FDA Drug
Yes

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06600607 on ClinicalTrials.gov