Back to resultsA Phase 1b Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419
Primary Purpose
Peripheral Neuropathic Pain
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
SR419
active control
SR419 placebo
active control placebo
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Neuropathic Pain focused on measuring DPN, PHN...etc.
Eligibility Criteria
Inclusion Criteria:
- Aged ≥18 years at the time of informed consent.
- Be diagnosed as suffering from chronic peripheral neuropathic pain, and specifically PHN or DPN.
- 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.
- A minimum score of 19 on the pain DETECT questionnaire.
Exclusion Criteria:
- Being pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study.
- Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality.
- Known or suspected intolerance or hypersensitivity to any of the study drugs, close related compounds, or any of the stated ingredients.
- 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.
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Creatinine clearance as estimated by estimated glomerular filtration rate (eGFR) <60 mL/min.
- A history of major psychiatric disorder(s).
Sites / Locations
- Clinical Research Facility Medical School, University of Adelaide
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Treatment A
Treatment B
Treatment C
Arm Description
Treatment A: Single 20 mg oral suspension dose of SR419 + single active control placebo capsule.
Treatment B: Single SR419 placebo oral suspension + single 300 mg oral capsule of active control.
Treatment C: Single SR419 placebo oral suspension + single active control placebo capsule.
Outcomes
Primary Outcome Measures
QST of an affected area.
QST: Quantitative sensory testing
Secondary Outcome Measures
The incidence, frequency, and severity of TEAEs.
TEAE: Treatment-Emergent Adverse Events
Spontaneous pain score
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).
QST of an unaffected area.
Plasma concentration of SR419 after dosing.
Full Information
NCT ID
NCT04494815
First Posted
July 28, 2020
Last Updated
August 2, 2022
Sponsor
SIMR (Australia) Biotech Pty Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04494815
Brief Title
A Phase 1b Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 18, 2020 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SIMR (Australia) Biotech Pty Ltd.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419 in Patients with Peripheral Neuropathic Pain
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathic Pain
Keywords
DPN, PHN...etc.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A
Arm Type
Experimental
Arm Description
Treatment A: Single 20 mg oral suspension dose of SR419 + single active control placebo capsule.
Arm Title
Treatment B
Arm Type
Active Comparator
Arm Description
Treatment B: Single SR419 placebo oral suspension + single 300 mg oral capsule of active control.
Arm Title
Treatment C
Arm Type
Placebo Comparator
Arm Description
Treatment C: Single SR419 placebo oral suspension + single active control placebo capsule.
Intervention Type
Drug
Intervention Name(s)
SR419
Intervention Description
Each participant will receive 1 dose of 20 mg SR419 oral suspension.
Intervention Type
Drug
Intervention Name(s)
active control
Intervention Description
Each participant will receive 1 dose of 300 mg active control capsule.
Intervention Type
Drug
Intervention Name(s)
SR419 placebo
Intervention Description
Each participant will receive 2 doses of SR419 placebo oral suspension.
Intervention Type
Drug
Intervention Name(s)
active control placebo
Intervention Description
Each participant will receive 2 doses of active control placebo capsule.
Primary Outcome Measure Information:
Title
QST of an affected area.
Description
QST: Quantitative sensory testing
Time Frame
Up to Day18(-2~+5) for the safety follow up since Day1
Secondary Outcome Measure Information:
Title
The incidence, frequency, and severity of TEAEs.
Description
TEAE: Treatment-Emergent Adverse Events
Time Frame
Up to Day18(-2~+5) for the safety follow up since Day1
Title
Spontaneous pain score
Description
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).
Time Frame
Up to Day18(-2~+5) for the safety follow up since Day1
Title
QST of an unaffected area.
Time Frame
Up to Day18(-2~+5) for the safety follow up since Day1
Title
Plasma concentration of SR419 after dosing.
Time Frame
Up to Day11(+3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged ≥18 years at the time of informed consent.
Be diagnosed as suffering from chronic peripheral neuropathic pain, and specifically PHN or DPN.
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.
A minimum score of 19 on the pain DETECT questionnaire.
Exclusion Criteria:
Being pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study.
Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality.
Known or suspected intolerance or hypersensitivity to any of the study drugs, close related compounds, or any of the stated ingredients.
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.
Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
Creatinine clearance as estimated by estimated glomerular filtration rate (eGFR) <60 mL/min.
A history of major psychiatric disorder(s).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Wu
Organizational Affiliation
SIMR
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Facility Medical School, University of Adelaide
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
A Phase 1b Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419
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