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

Pain Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05484414
• Other study ID #: SRP-101
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 16, 2022
• Est. completion date: February 28, 2024

Study information

• Verified date: November 2023
• Source: South Rampart Pharma, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: February 28, 2024
• Est. primary completion date: October 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
United States	Quotient Sciences-Miami, Inc.	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
South Rampart Pharma, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Reported AEs	The time of providing written informed consent until 30 days after the last dose of study drug
Secondary	PK parameters	Lag time (Tlag)	6 days
Secondary	PK parameters	Time to reach maximum (peak) plasma concentration following drug administration (Tmax)	6 days
Secondary	PK parameters	Maximum (peak) plasma drug concentration (Cmax)	6 days
Secondary	PK parameters	Area under the plasma concentration-time curve from time zero to infinity (AUCinf)	6 days
Secondary	PK parameters	Area under the plasma concentration-time curve from time zero to infinity (AUClast)	6 days
Secondary	PK parameters	Area under the plasma concentration-time curve (AUC0-tau)	6 days
Secondary	PK parameters	Terminal disposition rate constant/terminal rate constant (?z)	6 days
Secondary	PK parameters	Elimination half-life (T1/2)	6 days
Secondary	PK parameters	Apparent total clearance of the drug from plasma after oral administration (CL/F)	6 days
Secondary	PK parameters	Apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F)	6 days