Back to resultsSafety and Pharmacokinetics of SAD/MAD Oral Doses of SRP-3D (DA)
Primary Purpose
Pain
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SRP-3D (diethylamide)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Pain
Eligibility Criteria
Inclusion Criteria:
- Healthy male or female. Females must not be pregnant or breastfeeding.
- Is between 18 and 55 years of age (inclusive).
- Able to speak and understand English or Spanish.
- Agrees to comply with testing procedures.
- Has a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive).
- The subject meets good health criteria.
- Females of non-childbearing potential or agree to use birth control.
- Male subjects must be surgically sterile or agree to the use birth control.
- Agree to the confinement period and return for the outpatient visits.
- Has vital signs at screening within appropriate ranges.
Exclusion Criteria:
- History or presence of clinically significant diseases.
- Abnormal diet 4 weeks preceding the first dose of study medication.
- Received any investigational product in a clinical study.
- Previously been administered IMP in this study.
- Taking any prescribed or OTC drug.
- Taking moderate or strong inhibitors/inducers of cytochrome P450.
- History of hypersensitivity to acetaminophen or similar chemical entities.
- Presence or history of allergy or blood or plasma donation.
- Blood or plasma donation
- Smokers and those who have smoked within the last 12 months.
- Current users of e-cigarettes and nicotine replacement products.
- Consumption of prohibited beverages or foods.
- Prior history of substance abuse or treatment.
- Regular alcohol consumption.
- Positive alcohol urine test at screening or admission.
- Is a female with a positive pregnancy test result.
- Positive urine screen for drugs of abuse.
- Positive test for hepititus B or C, or HIV.
- Active infection, periodontal disease,. certain dental appliances.
- Glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
- Significant serious skin disease.
- Cohort 3 only: history of cholecystectomy or gall stones.
- Have poor venous access that limits phlebotomy
- Evidence of current SARS-CoV-2 infection
- Clinically significant abnormal clinical chemistry, hematology or urinalysis.
- Immediate family members of a study site or Sponsor employee.
- Failure to satisfy the Investigator of fitness to participate.
Sites / Locations
- Quotient Sciences-Miami, Inc.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental
Placebo
Arm Description
SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
Outcomes
Primary Outcome Measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Reported AEs
Secondary Outcome Measures
PK parameters
Lag time (Tlag)
PK parameters
Time to reach maximum (peak) plasma concentration following drug administration (Tmax)
PK parameters
Maximum (peak) plasma drug concentration (Cmax)
PK parameters
Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
PK parameters
Area under the plasma concentration-time curve from time zero to infinity (AUClast)
PK parameters
Area under the plasma concentration-time curve (AUC0-tau)
PK parameters
Terminal disposition rate constant/terminal rate constant (λz)
PK parameters
Elimination half-life (T1/2)
PK parameters
Apparent total clearance of the drug from plasma after oral administration (CL/F)
PK parameters
Apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F)
Full Information
NCT ID
NCT05484414
First Posted
July 27, 2022
Last Updated
August 3, 2022
Sponsor
South Rampart Pharma, LLC
1. Study Identification
Unique Protocol Identification Number
NCT05484414
Brief Title
Safety and Pharmacokinetics of SAD/MAD Oral Doses of SRP-3D (DA)
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2023 (Anticipated)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
South Rampart Pharma, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
Intervention Type
Drug
Intervention Name(s)
SRP-3D (diethylamide)
Other Intervention Name(s)
SRP-3D (DA)
Intervention Description
SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control
Intervention Description
Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Reported AEs
Time Frame
The time of providing written informed consent until 30 days after the last dose of study drug
Secondary Outcome Measure Information:
Title
PK parameters
Description
Lag time (Tlag)
Time Frame
6 days
Title
PK parameters
Description
Time to reach maximum (peak) plasma concentration following drug administration (Tmax)
Time Frame
6 days
Title
PK parameters
Description
Maximum (peak) plasma drug concentration (Cmax)
Time Frame
6 days
Title
PK parameters
Description
Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Time Frame
6 days
Title
PK parameters
Description
Area under the plasma concentration-time curve from time zero to infinity (AUClast)
Time Frame
6 days
Title
PK parameters
Description
Area under the plasma concentration-time curve (AUC0-tau)
Time Frame
6 days
Title
PK parameters
Description
Terminal disposition rate constant/terminal rate constant (λz)
Time Frame
6 days
Title
PK parameters
Description
Elimination half-life (T1/2)
Time Frame
6 days
Title
PK parameters
Description
Apparent total clearance of the drug from plasma after oral administration (CL/F)
Time Frame
6 days
Title
PK parameters
Description
Apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F)
Time Frame
6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male or female. Females must not be pregnant or breastfeeding.
Is between 18 and 55 years of age (inclusive).
Able to speak and understand English or Spanish.
Agrees to comply with testing procedures.
Has a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive).
The subject meets good health criteria.
Females of non-childbearing potential or agree to use birth control.
Male subjects must be surgically sterile or agree to the use birth control.
Agree to the confinement period and return for the outpatient visits.
Has vital signs at screening within appropriate ranges.
Exclusion Criteria:
History or presence of clinically significant diseases.
Abnormal diet 4 weeks preceding the first dose of study medication.
Received any investigational product in a clinical study.
Previously been administered IMP in this study.
Taking any prescribed or OTC drug.
Taking moderate or strong inhibitors/inducers of cytochrome P450.
History of hypersensitivity to acetaminophen or similar chemical entities.
Presence or history of allergy or blood or plasma donation.
Blood or plasma donation
Smokers and those who have smoked within the last 12 months.
Current users of e-cigarettes and nicotine replacement products.
Consumption of prohibited beverages or foods.
Prior history of substance abuse or treatment.
Regular alcohol consumption.
Positive alcohol urine test at screening or admission.
Is a female with a positive pregnancy test result.
Positive urine screen for drugs of abuse.
Positive test for hepititus B or C, or HIV.
Active infection, periodontal disease,. certain dental appliances.
Glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
Significant serious skin disease.
Cohort 3 only: history of cholecystectomy or gall stones.
Have poor venous access that limits phlebotomy
Evidence of current SARS-CoV-2 infection
Clinically significant abnormal clinical chemistry, hematology or urinalysis.
Immediate family members of a study site or Sponsor employee.
Failure to satisfy the Investigator of fitness to participate.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Manager
Phone
8007693518
Email
info@southrampartpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hernan A Bazan, MD
Organizational Affiliation
CEO
Official's Role
Study Chair
Facility Information:
Facility Name
Quotient Sciences-Miami, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
305-644-9903
Ext
115
Email
maria.bermudez@quotientsciences.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Pharmacokinetics of SAD/MAD Oral Doses of SRP-3D (DA)
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