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

December 5, 2024 updated by: South Rampart Pharma, LLC

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
Drug: SRP-3D (diethylamide)
SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
Other Names:
  • SRP-3D (DA)
Placebo Comparator: Placebo
Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
Drug: Placebo
Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: The time of providing written informed consent until 30 days after the last dose of study drug
Reported AEs
The time of providing written informed consent until 30 days after the last dose of study drug

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PK parameters 1
Time Frame: 6 days
Lag time (Tlag)
6 days
PK parameters 2
Time Frame: 6 days
Time to reach maximum (peak) plasma concentration following drug administration (Tmax)
6 days
PK parameters 3
Time Frame: 6 days
Maximum (peak) plasma drug concentration (Cmax)
6 days
PK parameters 4
Time Frame: 6 days
Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
6 days
PK parameters 5
Time Frame: 6 days
Area under the plasma concentration-time curve from time zero to infinity (AUClast)
6 days
PK parameters 6
Time Frame: 6 days
Area under the plasma concentration-time curve (AUC0-tau)
6 days
PK parameters 7
Time Frame: 6 days
Terminal disposition rate constant/terminal rate constant (λz)
6 days
PK parameters 8
Time Frame: 6 days
Elimination half-life (T1/2)
6 days
PK parameters 9
Time Frame: 6 days
Apparent total clearance of the drug from plasma after oral administration (CL/F)
6 days
PK parameters 10
Time Frame: 6 days
Apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F)
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
South Rampart Pharma, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hernan A Bazan, MD, CEO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 16, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SRP-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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