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Not yet recruiting NCT05484414

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

Phase I Interventional Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SRP-3D (diethylamide), Placebo.
Who it may be relevant to
Registry conditions: Pain. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • 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

Primary outcome measures

  • 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]
Secondary outcome measures (10)
  • PK parameters 1 [Time frame: 6 days]
  • PK parameters 2 [Time frame: 6 days]
  • PK parameters 3 [Time frame: 6 days]
  • PK parameters 4 [Time frame: 6 days]
  • PK parameters 5 [Time frame: 6 days]
  • PK parameters 6 [Time frame: 6 days]
  • PK parameters 7 [Time frame: 6 days]
  • PK parameters 8 [Time frame: 6 days]
  • PK parameters 9 [Time frame: 6 days]
  • PK parameters 10 [Time frame: 6 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Quotient Sciences-Miami, Inc. — Miami

Identifiers

NCT: NCT05484414 · SRP-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗