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

NCT06600607 | Completed Early Phase 1 FDA Drug

• 1 other identifier: LTG-OBS-102
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change from baseline pain score after dosing with pregabalin vs. placebo

  Numerical Pain Rating Scale (NPRS) will be assessed during Cold Pressor Tests at various time points for time to reach Pain Detection Threshold (PDT) and time to reach Pain Tolerance Threshold (PTT)

  0-12 hours during each treatment period

• Time to reach Pain Detection Threshold (PDT) and Pain Tolerance Threshold (PTT) after dosing with pregabalin vs placebo

  Stopwatches will be used during each cold pressor test to determine time for subject to reach PDT and PTT

  0-12 hours during each treatment period

Study Arms (2)

Schedule A

OTHER

participants receive pregabalin 300mg in treatment period 1, and receive placebo in treatment period 2

Drug: pregabalin 300 mg; Other: Placebo

Schedule B

OTHER

participants receive placebo in treatment period 1, and receive pregabalin 300mg in treatment period 2

Drug: pregabalin 300 mg; Other: Placebo

Interventions

pregabalin 300 mg DRUG

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

Schedule A; Schedule B

Placebo OTHER

biologically inactive placebo comparator

Schedule A; Schedule B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male participants aged 18 to 55 years, inclusive, at the time of signing the informed consent.
• Overtly healthy with no clinically relevant abnormalities based on the medical history, physical examinations, clinical laboratory evaluations, and 12-lead ECG that, in the opinion of the investigator, would affect participant safety.
• Body mass index (BMI) within the range of 18-32 kg/m2 (inclusive).
• Male participants are eligible to participate if they agree to refrain from donating semen. Plus, agree to use a male condom when having sexual intercourse with woman of childbearing potential or women who are currently pregnant.
• Capable of giving signed informed consent.

You may not qualify if:

• Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption.
• Clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the investigator, unacceptably increase the participant's risk by participating in the study.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), \>1.5 x upper limit of normal (ULN) at Screening.
• Total bilirubin \> 1.5 x ULN (for participants with known Gilbert's syndrome these criteria only apply if total bilirubin \> 1.5 x ULN as long as direct bilirubin is ≤ 1.5 x ULN) at Screening.
• Estimated glomerular filtration rate (eGFR) \<80 mL/min based on serum creatinine levels using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine equation at Screening.
• Creatinine phosphokinase is ≤ 2 × ULN at Screening.
• Any of the protocol defined abnormalities on 12-lead ECG or blood pressure (BP) at Screening, confirmed by repeat.
• Use of prescription drugs ≤ 14 days (or 5 half-lives of the drug, whichever is longer) prior to Day 1, use of over-the-counter drugs, herbal medications, or vitamin supplements ≤ 7 days (or 5 half-lives of the drug, whichever is longer) prior to Day 1 or use of antibiotics and systemic steroids ≤ 28 days prior Day 1. The Sponsor may allow exceptions only if the medication's administration is deemed unlikely to confound safety.
• Any vaccination ≤ 14 days prior to Day 1 or anticipated vaccination while participating in the study.
• Receipt of an investigational product or device, or participation in a drug research study ≤ 28 days (or 5 half-lives of the drug, whichever is longer) prior to Day 1.
• Receipt of an investigational biologic / monoclonal antibody within 180 days (or 5 half-lives, whichever is longer) prior to Day 1.
• Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at Screening.
• Presence of positive hepatitis C antibody test result at Screening.
• Positive for Coronavirus Disease 2019 (COVID-19) suggesting active infection at Screening or on Day 1.
• Positive human immunodeficiency virus (HIV) at Screening.

Sponsors & Collaborators

• Latigo Biotherapeutics: lead

Study Sites (1)

New Zealand Clinical Research

Christchurch, New Zealand

Location

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: October 7, 2024
• Primary Completion: October 27, 2024
• Study Completion: October 27, 2024
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)