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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- QST of an affected area.
研究概览
简要总结
This study is to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419 in Patients with Peripheral Neuropathic Pain
详细描述
This is a 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Treatment A
Treatment A: Single 20 mg oral suspension dose of SR419 + single active control placebo capsule.
干预措施: SR419 (Drug)
Treatment A
Treatment A: Single 20 mg oral suspension dose of SR419 + single active control placebo capsule.
干预措施: active control placebo (Drug)
Treatment B
Treatment B: Single SR419 placebo oral suspension + single 300 mg oral capsule of active control.
干预措施: active control (Drug)
Treatment B
Treatment B: Single SR419 placebo oral suspension + single 300 mg oral capsule of active control.
干预措施: SR419 placebo (Drug)
Treatment C
Treatment C: Single SR419 placebo oral suspension + single active control placebo capsule.
干预措施: active control (Drug)
Treatment C
Treatment C: Single SR419 placebo oral suspension + single active control placebo capsule.
干预措施: active control placebo (Drug)
结局指标
主要结局
QST of an affected area.
时间窗: Up to Day18(-2~+5) for the safety follow up since Day1
QST: Quantitative sensory testing
次要结局
- QST of an unaffected area.(Up to Day18(-2~+5) for the safety follow up since Day1)
- The incidence, frequency, and severity of TEAEs.(Up to Day18(-2~+5) for the safety follow up since Day1)
- Spontaneous pain score(Up to Day18(-2~+5) for the safety follow up since Day1)
- Plasma concentration of SR419 after dosing.(Up to Day11(+3))