Pain
Conditions
Keywords
Pain
Brief summary
This is a two-part randomized, double-blind, placebo-controlled study.
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).
Interventions
DRUGSRP-3D (diethylamide)
SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
DRUGPlacebo
Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
Sponsors
South Rampart Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | The time of providing written informed consent until 30 days after the last dose of study drug | Reported AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK parameters 1 | 6 days | Lag time (Tlag) |
| PK parameters 2 | 6 days | Time to reach maximum (peak) plasma concentration following drug administration (Tmax) |
| PK parameters 3 | 6 days | Maximum (peak) plasma drug concentration (Cmax) |
| PK parameters 4 | 6 days | Area under the plasma concentration-time curve from time zero to infinity (AUCinf) |
| PK parameters 5 | 6 days | Area under the plasma concentration-time curve from time zero to infinity (AUClast) |
| PK parameters 6 | 6 days | Area under the plasma concentration-time curve (AUC0-tau) |
| PK parameters 7 | 6 days | Terminal disposition rate constant/terminal rate constant (λz) |
| PK parameters 8 | 6 days | Elimination half-life (T1/2) |
| PK parameters 9 | 6 days | Apparent total clearance of the drug from plasma after oral administration (CL/F) |
| PK parameters 10 | 6 days | Apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F) |
Countries
United States
Contacts
STUDY_CHAIRHernan A Bazan, MD
CEO
Outcome results
None listed