A Phase 1, Partially Blinded, Randomized, Crossover Study to Evaluate the Pharmacokinetics and QT/QTc Interval of ESK-001 Compared to Placebo and Moxifloxacin in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Alumis Inc
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change from baseline in placebo-adjusted QTcF (∆∆QTcF)
研究概览
简要总结
This a phase 1, partially blinded, randomized, crossover study to determine the pharmacokinetics (PK) and QT/QTc interval of study drug (ESK-001) in healthy volunteer participants,
详细描述
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
All subjects will be randomized to 1 of 4 treatment sequences; each subject will receive all 4 treatments. Treatments 1 through 3 will be blinded; Treatment 4 will be given open label. The central ECG laboratory will be blinded to treatment assignment
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
- •Healthy male and female subjects aged between 18 and 55 years, inclusive. Body mass index between ≥18.0 and ≤32.0 kg/m2, inclusive, and a minimum body weight of 45 kg.
- •Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- •In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations, and from the physical examination at screening or check-in, as assessed by the investigator (or designee).
- •Serum sodium, potassium, calcium, and magnesium levels are within the normal range at screening and check-in-
排除标准
- •Positive hepatitis panel and/or positive human immunodeficiency virus test, hepatitis B surface antigen, or hepatitis C antibodies.
- •Alanine aminotransferase or aspartate aminotransferase >1.5 times the upper limit of normal, at screening or check-in.
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator (or designee).
- •Surgery within the past three months prior to the first study drug administration determined by the principal investigator to be clinically relevant.
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed).
- •History of Gilbert's syndrome or cholecystectomy surgery.
研究组 & 干预措施
Treatment 1: (Therapeutic dose)
1 oral dose of ESK-001
干预措施: ESK-001 (Drug)
Treatment 2: (Supratherapeutic dose)
1 oral dose of ESK-001
干预措施: ESK-001 (Drug)
Treatment 3: ESK-001-matched placebo
干预措施: Placebo (Drug)
Treatment 4: (positive control)
Moxifloxacin 400 mg tablet
干预措施: Moxifloxacin (400 mg) (Drug)
结局指标
主要结局
Change from baseline in placebo-adjusted QTcF (∆∆QTcF)
时间窗: 24 hours
次要结局
- Change from baseline in ECG parameter ΔHR(24 hours)
- Change from baseline in ECG parameter Δ PR interval(24 hours)
- Change from baseline in ECG parameter ΔQRS duration(24 hours)
- Change from baseline in ECG parameter ΔQTc interval(24 hours)
- Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation(Up to 22 Days)
- Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations(Up to 22 Days)
- Composite of pharmacokinetic (PK) parameter Vz/F for ESK-001 and metabolites(24 hours)
- Composite of pharmacokinetic (PK) parameter Cmax for ESK-001 and metabolites(24 hours)
- Composite of pharmacokinetic (PK) parameter tmax for ESK-001 and metabolites(24 hours)
- Composite of pharmacokinetic (PK) parameter CL/F for ESK-001 and metabolites(24 hours)