A Phase 2 Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants With Methamphetamine Use Disorder Not Seeking Treatment Receiving a Single Dose of Methamphetamine
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 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, efficacy, and pharmacokinetics of four single, increasing doses of CS-1103, given by intravenous (IV) infusion in otherwise healthy, non-treatment seeking participants with methamphetamine use disorder in the presence of a clinically relevant dose of methamphetamine HCl (30 mg IV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- 否
入选标准
- •Major Inclusion Criteria:
- •Healthy participants aged 18 to 55 years, inclusive;
- •Meets DSM-5 criteria for methamphetamine use disorder;
- •Not seeking treatment for methamphetamine use disorder;
- •Primary route of methamphetamine self-administration must be intravenous or smoking;
- •Able to abstain from methamphetamine without experiencing severe withdrawal;
- •A body mass index between 18 to 30 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 <60 mL/min/1.73 m2;
- •History of cardiovascular disease;
- •Current moderate to severe use disorder for alcohol, cannabis, cocaine, opioids, or benzodiazepines;
- •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
Placebo
Participants receive methamphetamine HCl (30 mg) followed by placebo (saline).
干预措施: Methamphetamine (Drug)
Active
Participants receive methamphetamine HCl (30 mg) followed by one of four doses of CS-1103
干预措施: Methamphetamine (Drug)
Active
Participants receive methamphetamine HCl (30 mg) followed by one of four doses of CS-1103
干预措施: CS-1103 (Drug)
Placebo
Participants receive methamphetamine HCl (30 mg) 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 and magnitude of urine excretion of methamphetamine
时间窗: 48 hours
Measurement of concentration of methamphetamine in urine
次要结局
- Time course of CS-1103 blood and urine concentrations(48 hours)