A Single-center, Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SUVN-G3031 After Single Ascending Doses and Multiple Ascending Doses in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Safety and tolerability of single or multiple doses of SUVN-G3031 in healthy male subjects
研究概览
简要总结
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of SUVN-G3031 in healthy male subjects following single or multiple ascending doses.
详细描述
This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-G3031 administered orally once a day to healthy male subjects. The study will be conducted under double-blind conditions.
The primary objective is to evaluate the safety and tolerability of SUVN-G3031 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-G3031, if possible.
The secondary objectives are to evaluate the single and repeat dose plasma pharmacokinetics following oral administration of single and multiple ascending doses of SUVN-G3031 in healthy male subjects.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male aged 18 to 45 years with a BMI between 18 and 30 kg/m2, (inclusive).
排除标准
- •Standard exclusion criterion for Phase 1 clinical trial in healthy subjects.
- •History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
- •History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
研究组 & 干预措施
Single ascending dose
Single dose of SUVN-G3031or placebo in healthy male subjects
干预措施: SUVN-G3031 (Drug)
Single ascending dose
Single dose of SUVN-G3031or placebo in healthy male subjects
干预措施: Placebo (Drug)
Multiple ascending dose
Multiple doses of SUVN-G3031 or placebo in healthy male subjects
干预措施: SUVN-G3031 (Drug)
Multiple ascending dose
Multiple doses of SUVN-G3031 or placebo in healthy male subjects
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of single or multiple doses of SUVN-G3031 in healthy male subjects
时间窗: Range of Day 1-19
Safety variables - Adverse events, vital signs, electrocardiograms, telemetry, physical examination, and clinical laboratory assessments.
次要结局
- Accumulation index following multiple dosing of SUVN-G3031 (AI)(Day 14)
- Area under the SUVN-G3031 plasma concentration-time curve in a dosing interval (AUC0-tau)(Day 1)
- Area under the SUVN-G3031 plasma concentration-time curve from zero to infinity (AUC0-inf)(Day 14)
- Maximum observed concentration (Cmax) and time of observation (tmax)(Day 1 and Day 14)
- Oral clearance (CL/F), apparent volume of distribution (Vz/F), and elimination half life (t½)(Day 1 and Day 14)