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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06600607




Registration number
NCT06600607
Ethics application status
Date submitted
13/09/2024
Date registered
19/09/2024

Titles & IDs
Public title
Pharmacodynamic Study of 300mg Pregabalin Vs Placebo in Healthy Male Adults
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Crossover Study to Evaluate the Pharmacodynamic Effects of Pregabalin in Healthy Male Adults
Secondary ID [1] 0 0
LTG-OBS-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain Detection 0 0
Pain Threshold 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - pregabalin 300 mg
Other interventions - Placebo

Other: Schedule A - participants receive pregabalin 300mg in treatment period 1, and receive placebo in treatment period 2

Other: Schedule B - participants receive placebo in treatment period 1, and receive pregabalin 300mg in treatment period 2


Treatment: Drugs: pregabalin 300 mg
pregabalin is an FDA-approved anticonvulsant medication commonly used to treat nerve pain

Other interventions: Placebo
biologically inactive placebo comparator
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline pain score after dosing with pregabalin vs. placebo
Timepoint [1] 0 0
0-12 hours during each treatment period
Primary outcome [2] 0 0
Time to reach Pain Detection Threshold (PDT) and Pain Tolerance Threshold (PTT) after dosing with pregabalin vs placebo
Timepoint [2] 0 0
0-12 hours during each treatment period

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/09/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Latigo Biotherapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Chief Medical Officer
Address 0 0
Country 0 0
Phone 0 0
626-862-7778
Fax 0 0
Email 0 0
nsingla@latigobio.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06600607