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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain Threshold; Pain Detection
• Intervention / Treatment: Drug: pregabalin 300 mg; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Christchurch, New Zealand
    • New Zealand Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male participants aged 18 to 55 years, inclusive, at the time of signing the informed consent.
2. 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.
3. Body mass index (BMI) within the range of 18-32 kg/m2 (inclusive).
4. 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.
5. Capable of giving signed informed consent.

Exclusion Criteria:

1. Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption.
2. 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.
3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), >1.5 x upper limit of normal (ULN) at Screening.
4. 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.
5. 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.
6. Creatinine phosphokinase is ≤ 2 × ULN at Screening.
7. Any of the protocol defined abnormalities on 12-lead ECG or blood pressure (BP) at Screening, confirmed by repeat.
8. 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.
9. Any vaccination ≤ 14 days prior to Day 1 or anticipated vaccination while participating in the study.
10. 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.
11. Receipt of an investigational biologic / monoclonal antibody within 180 days (or 5 half-lives, whichever is longer) prior to Day 1.
12. Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at Screening.
13. Presence of positive hepatitis C antibody test result at Screening.
14. Positive for Coronavirus Disease 2019 (COVID-19) suggesting active infection at Screening or on Day 1.
15. Positive human immunodeficiency virus (HIV) at Screening.
16. Presence of any condition for which pregabalin administration is contraindicated.
17. Smoking, vaping or use of tobacco or any products containing nicotine ≤ 14 days prior to Day 1.
18. Consumption of alcohol within 48 hours prior to Day 1 and/or food and beverages containing methylxanthines (caffeinated coffee, caffeinated tea, caffeinated soda, and chocolate) within 48 hours of Day 1, and grapefruit, grapefruit juice, Seville oranges, or Seville orange juice ≤ 14 days prior to Day 1.
19. Positive urine drug screen, urine cotinine test, or alcohol breath test at Screening or on Day 1.
20. Donation of over 500 mL blood ≤ 3 months prior to Day 1.
21. Has known psychiatric disorders that would interfere with the cooperation with the requirements of the study.
22. Participant is under legal custodianship.
23. Pain conditions that may require analgesic treatment during the study period/history of opioid medication use.
24. Hand/arm/skin conditions impacting ability to participate in cold pressor assessment.
25. Recent serious injury, surgical procedure, or medical condition which, in the opinion of the investigator, unacceptably increases the participant's risk by being included in the study.
26. Meets protocol defined Pain Tolerance Threshold (PTT) in any of the 5 predose cold pressor tests.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Schedule A; participants receive pregabalin 300mg in treatment period 1, and receive placebo in treatment period 2	Drug: pregabalin 300 mg; pregabalin is an FDA-approved anticonvulsant medication commonly used to treat nerve pain; Other: Placebo; biologically inactive placebo comparator
Other: Schedule B; participants receive placebo in treatment period 1, and receive pregabalin 300mg in treatment period 2	Drug: pregabalin 300 mg; pregabalin is an FDA-approved anticonvulsant medication commonly used to treat nerve pain; Other: Placebo; biologically inactive placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Latigo Biotherapeutics

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2024
• Primary Completion (Actual): October 27, 2024
• Study Completion (Actual): October 27, 2024

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Membrane Transport Modulators; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anticonvulsants; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: LTG-OBS-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes