A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of a Single Dose of Intravenous CS 1103 Following a Single Intravenous Dose of Fentanyl in Healthy Subjects With Naloxone Blockade
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations
研究概览
简要总结
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CS-1103 (1,000 mg), given by intravenous (IV) infusion in healthy participants in the presence of a clinically relevant dose of fentanyl (200 μg, IV), with naloxone blockade (400 μg, IV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Major Inclusion Criteria:
- •Healthy participants aged 18 to 55 years, inclusive;
- •Have prior experience with opioids, such as from a dental procedure, chronic pain management, or previous inpatient surgical procedure;
- •A body mass index between 18.0 to 30.0 kg/m2, inclusive, and a minimum body weight of 56 kg;
- •Females must not be lactating and must have a negative pregnancy test during screening and admission.
排除标准
- •Estimated glomerular filtration rate <90 mL/min/1.73 m2;
- •History of cardiovascular disease;
- •History of any clinically important disease or disorder which, in the opinion of the Investigator, may interfere with safe study participation.
研究组 & 干预措施
Active
Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by CS-1103 (1,000 mg, IV).
干预措施: CS-1103 (Drug)
Placebo
Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by placebo (saline).
干预措施: Naloxone Hydrochloride (Drug)
Placebo
Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by placebo (saline).
干预措施: Fentanyl (Drug)
Active
Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by CS-1103 (1,000 mg, IV).
干预措施: Naloxone Hydrochloride (Drug)
Active
Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by CS-1103 (1,000 mg, IV).
干预措施: Fentanyl (Drug)
Placebo
Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by placebo (saline).
干预措施: Sterile Saline (Drug)
结局指标
主要结局
Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations
时间窗: 3 days plus follow-up on Day 10
Physical examinations
Number of participants with CS-1103-related adverse events (AEs) assessed by electrocardiograms (ECGs)
时间窗: 3 days plus follow-up on Day 10
Digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted
Number of participants with CS-1103-related adverse events (AEs) assessed by vital signs
时间窗: 3 days plus follow-up on Day 10
Blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature
Number of participants with CS-1103-related adverse events (AEs) assessed by laboratory parameters
时间窗: 3 days plus follow-up on Day 10
Clinical chemistry, hematology, coagulation, and urinalysis
Time course of CS-1103 blood and urine concentrations
时间窗: 48 hours
Measurement of plasma and urine concentrations of CS-1103
Time course and magnitude of urine excretion of fentanyl
时间窗: 48 hours
Measurement of concentration of fentanyl in urine
次要结局
- Effect of CS-1103 and fentanyl on QT interval(48 hours)
- Effect of CS-1103 on the naloxone plasma and urine PK, if any(48 hours)