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NCT05484414 | NOT YET RECRUITING | Pain

Safety and Pharmacokinetics of SAD/MAD Oral Doses of SRP-3D (DA)
Sponsor:

South Rampart Pharma, LLC

Brief Summary:

This is a two-part randomized, double-blind, placebo-controlled study.

Condition or disease

Pain

Intervention/treatment

SRP-3D (diethylamide)

Placebo

Phase

PHASE1

Detailed Description:

This is a two-part randomized, double-blind, placebo-controlled study. The study comprises a SAD (Part 1) assessment which will include a food effect assessment that contributes data to inform a subsequent MAD (Part 2) dose-ranging study. Safety measurements will be collected throughout the study for all subjects. Blood samples will be collected to determine the PK parameters of SRP-3D (DA).

Study Type : INTERVENTIONAL
Estimated Enrollment : 56 participants
Masking : QUADRUPLE
Masking Description : Double-blind
Primary Purpose : TREATMENT
Official Title : A 2 Part Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Pharmacokinetics of SAD/MAD Oral Doses of SRP-3D (DA), and to Characterize the Effect of Food on the Pharmacokinetics in Healthy Male and Female Subjects
Actual Study Start Date : 2025-07-16
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2026-03-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • 1. Healthy male or female. Females must not be pregnant or breastfeeding.
  • 2. Is between 18 and 55 years of age (inclusive).
  • 3. Able to speak and understand English or Spanish.
  • 4. Agrees to comply with testing procedures.
  • 5. Has a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive).
  • 6. The subject meets good health criteria.
  • 7. Females of non-childbearing potential or agree to use birth control.
  • 8. Male subjects must be surgically sterile or agree to the use birth control.
  • 9. Agree to the confinement period and return for the outpatient visits.
  • 10. Has vital signs at screening within appropriate ranges.
Exclusion Criteria
  • 1. History or presence of clinically significant diseases.
  • 2. Abnormal diet 4 weeks preceding the first dose of study medication.
  • 3. Received any investigational product in a clinical study.
  • 4. Previously been administered IMP in this study.
  • 5. Taking any prescribed or OTC drug.
  • 6. Taking moderate or strong inhibitors/inducers of cytochrome P450.
  • 7. History of hypersensitivity to acetaminophen or similar chemical entities.
  • 8. Presence or history of allergy or blood or plasma donation.
  • 9. Blood or plasma donation
  • 10. Smokers and those who have smoked within the last 12 months.
  • 11. Current users of e-cigarettes and nicotine replacement products.
  • 12. Consumption of prohibited beverages or foods.
  • 13. Prior history of substance abuse or treatment.
  • 14. Regular alcohol consumption.
  • 15. Positive alcohol urine test at screening or admission.
  • 16. Is a female with a positive pregnancy test result.
  • 17. Positive urine screen for drugs of abuse.
  • 18. Positive test for hepititus B or C, or HIV.
  • 19. Active infection, periodontal disease,. certain dental appliances.
  • 20. Glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
  • 21. Significant serious skin disease.
  • 22. Cohort 3 only: history of cholecystectomy or gall stones.
  • 23. Have poor venous access that limits phlebotomy
  • 24. Evidence of current SARS-CoV-2 infection
  • 25. Clinically significant abnormal clinical chemistry, hematology or urinalysis.
  • 26. Immediate family members of a study site or Sponsor employee.
  • 27. Failure to satisfy the Investigator of fitness to participate.
Safety and Pharmacokinetics of SAD/MAD Oral Doses of SRP-3D (DA)

Location Details

NCT05484414

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Florida

Quotient Sciences-Miami, Inc.

Miami, Florida, United States, 33126