Pain DetectionEarly Phase 1NCT06600607
Pharmacodynamic Study of 300mg Pregabalin vs Placebo in Healthy Male Adults
A Early Phase 1 study testing pregabalin 300 mg in people with Pain Detection and Pain Threshold, run by Latigo Biotherapeutics at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Detection, Pain Threshold
- What is being tested?
- pregabalin 300 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNew Zealand
- Study dates
- 7 Oct 2024to 27 Oct 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Presence of any condition for which pregabalin administration is contraindicated.
- Smoking, vaping or use of tobacco or any products containing nicotine ≤ 14 days prior to Day 1.
- 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.
- Positive urine drug screen, urine cotinine test, or alcohol breath test at Screening or on Day 1.
- Donation of over 500 mL blood ≤ 3 months prior to Day 1.
- Has known psychiatric disorders that would interfere with the cooperation with the requirements of the study.
- Participant is under legal custodianship.
- Pain conditions that may require analgesic treatment during the study period/history of opioid medication use.
- Hand/arm/skin conditions impacting ability to participate in cold pressor assessment.
- 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.
- Meets protocol defined Pain Tolerance Threshold (PTT) in any of the 5 predose cold pressor tests.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pain Detection, Pain Threshold
- Being tested
- pregabalin 300 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregabalin 300 mgDrug
pregabalin is an FDA-approved anticonvulsant medication commonly used to treat nerve pain
PlaceboOther
biologically inactive placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Schedule A | Other | participants receive pregabalin 300mg in treatment period 1, and receive placebo in treatment period 2 Receives: Drug: pregabalin 300 mg; Other: Placebo |
| Schedule B | Other | participants receive placebo in treatment period 1, and receive pregabalin 300mg in treatment period 2 Receives: Drug: pregabalin 300 mg; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 0-12 hours during each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start7 Oct 2024
- Primary completion27 Oct 2024
- Study completion27 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain DetectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latigo Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600607
- Sponsor's protocol ID
- LTG-OBS-102
- Status last verified
- Apr 2025
- First submitted
- 13 Sep 2024
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Crossover Study to Evaluate the Pharmacodynamic Effects of Pregabalin in Healthy Male Adults
- ClinicalTrials.gov ID
- NCT06600607
- Acronym / sponsor ID
- LTG-OBS-102
- Conditions
- Pain Detection, Pain Threshold
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Latigo BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 27 Oct 2024 (actual)
- Study completion
- 27 Oct 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schedule A | Other | Drug: pregabalin 300 mg, Other: Placeboparticipants receive pregabalin 300mg in treatment period 1, and receive placebo in treatment period 2 |
| Schedule B | Other | Drug: pregabalin 300 mg, Other: Placeboparticipants receive placebo in treatment period 1, and receive pregabalin 300mg in treatment period 2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pregabalin 300 mgpregabalin is an FDA-approved anticonvulsant medication commonly used to treat nerve pain | Drug | Schedule A, Schedule B |
| Placebobiologically inactive placebo comparator | Other | Schedule A, Schedule B |
Primary outcome
Change from baseline pain score after dosing with pregabalin vs. placebo
Time frame: 0-12 hours during each treatment period
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)
Time to reach Pain Detection Threshold (PDT) and Pain Tolerance Threshold (PTT) after dosing with pregabalin vs placebo
Time frame: 0-12 hours during each treatment period
Stopwatches will be used during each cold pressor test to determine time for subject to reach PDT and PTT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing pregabalin 300 mg in people with Pain Detection and Pain Threshold, run by Latigo Biotherapeutics at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline pain score after dosing with pregabalin vs. placebo (time frame: 0-12 hours during each treatment period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.