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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Peripheral Neuropathic Pain

Intervention / Treatment
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* Drug: SR419
* Drug: active control
* Drug: SR419 placebo
* Drug: active control placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QST of an affected area. | 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. | TEAE: Treatment-Emergent Adverse Events | Up to Day18(-2 +5) for the safety follow up since Day1 | 
| 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). | Up to Day18(-2 +5) for the safety follow up since Day1 | 
| QST of an unaffected area. |  | Up to Day18(-2 +5) for the safety follow up since Day1 | 
| Plasma concentration of SR419 after dosing. |  | Up to Day11(+3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DPN, PHN...etc.