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NCT05484414

PHASE1

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

Sponsor: South Rampart Pharma, Inc.

View on ClinicalTrials.gov

Summary

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

Official title: A Two-Part Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending and Multiple Ascending Oral Doses of SRP-3D (DA), and to Characterize the Effect of Food on the Pharmacokinetics of SRP-3D (DA), in Healthy Male and Female Subjects

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2021-12-30

Completion Date

2023-11-06

Last Updated

2026-09-10

Healthy Volunteers

Yes

Conditions

Pain

Interventions

DRUG

SRP-3D (diethylamide)

SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL

DRUG

Placebo

Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL

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 hepatitis 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.

Locations (1)

Quotient Sciences-Miami, Inc.

Miami, Florida, United States