A Phase 1b Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419

August 2, 2022 updated by: SIMR (Australia) Biotech Pty Ltd.

A Phase 1b, Randomised, Double-blind, Placebo- and Active Controlled, Single Dose Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419 in Patients With Peripheral Neuropathic Pain

This study is to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419 in Patients with Peripheral Neuropathic Pain

Study Overview

Detailed Description

This is a single center, three-period, complete crossover, double-blind, randomised, placebo- and active-controlled study to compare the preliminary efficacy of a single dose of SR419 to placebo and active control in patients with peripheral neuropathic pain. The study also aims to evaluate the safety, tolerability, and PK of single doses of SR419 in patients with peripheral neuropathic pain.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • 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 Locations

    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Clinical Research Facility Medical School, University of Adelaide

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

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged ≥18 years at the time of informed consent.
  2. Be diagnosed as suffering from chronic peripheral neuropathic pain, and specifically PHN or DPN.
  3. Average daily pain over the last week prior to Screening to be of at least moderate severity (a score of ≥4 on the 11-point numeric rating scale [NRS]) and be of face, limb or torso location.
  4. A minimum score of 19 on the pain DETECT questionnaire.

Exclusion Criteria:

  1. Being pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study.
  2. Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality.
  3. Known or suspected intolerance or hypersensitivity to any of the study drugs, close related compounds, or any of the stated ingredients.
  4. Participants on controlled-release opioids (e.g., morphine) unless on a stable dose of Morphine Equivalent Dose (assessed by the Faculty of Pain Medicine Opioids Calculator) of up to and including 60 mg/day, at the discretion of the Investigator. Participants on instant-release opioids (e.g., codeine, oxycodone) must withhold dosing for 12 hours prior to administration of study drug.
  5. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
  6. Creatinine clearance as estimated by estimated glomerular filtration rate (eGFR) <60 mL/min.
  7. A history of major psychiatric disorder(s).

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A
Treatment A: Single 20 mg oral suspension dose of SR419 + single active control placebo capsule.
Each participant will receive 1 dose of 20 mg SR419 oral suspension.
Each participant will receive 2 doses of active control placebo capsule.
Active Comparator: Treatment B
Treatment B: Single SR419 placebo oral suspension + single 300 mg oral capsule of active control.
Each participant will receive 1 dose of 300 mg active control capsule.
Each participant will receive 2 doses of SR419 placebo oral suspension.
Placebo Comparator: Treatment C
Treatment C: Single SR419 placebo oral suspension + single active control placebo capsule.
Each participant will receive 2 doses of active control placebo capsule.
Each participant will receive 1 dose of 300 mg active control capsule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QST of an affected area.
Time Frame: Up to Day18(-2~+5) for the safety follow up since Day1
QST: Quantitative sensory testing
Up to Day18(-2~+5) for the safety follow up since Day1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence, frequency, and severity of TEAEs.
Time Frame: Up to Day18(-2~+5) for the safety follow up since Day1
TEAE: Treatment-Emergent Adverse Events
Up to Day18(-2~+5) for the safety follow up since Day1
Spontaneous pain score
Time Frame: Up to Day18(-2~+5) for the safety follow up since Day1
Pain score will be assessed via painDETECT questionnaire with a value range of 0~38, which includes three situations: If a subject gets a score of 0~12, it means a neuropathic pain component is unlikely(less than 15% probability); if a score of 13~19, it means the result is ambiguous, however, a neuropathic pain component can be present; if the score is equal to or greater than nineteen, it means a neuropathic pain is likely(more than 90% probability).
Up to Day18(-2~+5) for the safety follow up since Day1
QST of an unaffected area.
Time Frame: Up to Day18(-2~+5) for the safety follow up since Day1
Up to Day18(-2~+5) for the safety follow up since Day1
Plasma concentration of SR419 after dosing.
Time Frame: Up to Day11(+3)
Up to Day11(+3)

Collaborators and Investigators

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

Investigators

  • Study Director: Kai Wu, SIMR

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 (Actual)

September 18, 2020

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

July 31, 2022

Study Registration Dates

First Submitted

July 28, 2020

First Submitted That Met QC Criteria

July 28, 2020

First Posted (Actual)

July 31, 2020

Study Record Updates

Last Update Posted (Actual)

August 5, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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