NCT06916897已完成1 期
A Phase 1, Open-Label Study to Evaluate the Effect of Verapamil and Food on the Pharmacokinetics of Sevasemten in Healthy Adult Subjects
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pharmacokinetic
研究概览
简要总结
The purposes of this Phase 1 study of sevasemten are to:
- Evaluate the effect of multiple-dose administration of verapamil on the single-dose of sevasemten in healthy adults
- Evaluate the safety and tolerability of a single dose of sevasemten administered with and without verapamil in healthy adult subjects.
- Evaluate the safety and tolerability of a single dose of sevasemten administered with and without food in healthy adult 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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult, male or female (of non-childbearing potential)18-60 years of age, inclusive, at the screening visit.
- •Continuous non-smoker who has not used nicotine and tobacco containing products for at least 3 months prior to the first dosing based on subject self-reporting.
- •Body mass index (BMI) ≥ 18.0 and < 30.0 kg/m2 at the screening visit.
- •Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or ECGs.
- •Willing and able to comply with the protocol.
排除标准
- •History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- •History or presence of alcohol or drug abuse (except for use of cannabis products) within the past 2 years prior to first dosing.
- •Female subjects of childbearing potential.
- •Alcohol consumption > 14 drinks per week for males or ˃ 7 drinks for females within 45 days prior to the screening visit.
- •Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit.
- •Any drugs known to be moderate or strong inducers of CYP3A4 enzymes/or P glycoprotein, including St. John's Wort, beginning 28 days prior to the first dosing.
- •Is lactose intolerant.
- •Participation in another clinical study within 30 days or within 5 half-lives (if known), prior to first dosing, whichever is longer.
研究组 & 干预措施
Treatment A: single dose sevasemten
Experimental
Single dose sevasemten administered on Day 1 under fasting conditions
干预措施: sevasemten (Drug)
Treatment B: multiple doses of verapamil and single dose of sevasemten
Experimental
Multiple doses of verapamil with a single dose of sevasemten under fasting conditions
干预措施: sevasemten (Drug)
Treatment B: multiple doses of verapamil and single dose of sevasemten
Experimental
Multiple doses of verapamil with a single dose of sevasemten under fasting conditions
干预措施: Verapamil (Drug)
Treatment C: single dose sevasemten and high-fat meal
Experimental
Single dose sevasemten under high-fat fed conditions
干预措施: sevasemten (Drug)
结局指标
主要结局
Pharmacokinetic
时间窗: up to 42 days of monitoring
The lag time, time delayed between drug administration and the onset of absorption (Tlag), for sevasemten and metabolites under fasting and fed conditions
次要结局
- Safety and Tolerability(Up to 46 days of monitoring)
研究者
研究点 (1)
Loading locations...
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