A Phase 1, Open-Label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of [14C]Varegacestat Following a Single Oral Dose in Healthy Adult Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- The mass balance of varegacestat following administration of a single oral dose (containing ~100 µCi) [14C]varegacestat in healthy adult male participants.
研究概览
简要总结
This clinical study is designed to study the mass balance of a single dose of varegacestat in healthy male participants.
详细描述
This is a single-center, open-label, Phase 1, mass balance study of varegacestat administered as a single oral dose (containing ~100 µCi) [14C]varegacestat in 6 healthy male participants.
Following completion of Screening and Day -1 assessments and an overnight fast of at least 10 hours, eligible participants will be administered a single dose (containing ~100 µCi) [14C]varegacestat as 2 oral capsules followed by approximately 240 mL room temperature filtered water on the morning of Day 1. Whole blood, plasma, urine, feces, and vomitus (if any, up to 24 hours post-dose) will be collected over at least 168 hours post-dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Be a male participant between 18 and 55 years of age, inclusive, at Screening.
- •Medically healthy based on the absence of clinically significant abnormal vital sign measurements, clinical laboratory test results (especially tests for renal and hepatic function), resting 12-lead Electrocardiogram (ECG) evaluation, and physical examination, as determined by the Investigator at Screening and the Check-In visit.
排除标准
- •Have taken an investigational drug or participated in a clinical trial evaluating an investigational drug or device within 30 days (or 5 half-lives) prior to the study drug dose, whichever is longer.
- •Have participated in a radiolabeled drug study or have been otherwise exposed to significant diagnostic (excluding dental X-rays), therapeutic, or occupational radiation, where exposure is made known to the Investigator, within one year prior to admission to the clinic for this study. The total estimated 12-month exposure to radio material or ionizing radiation should be below the CFR recommended levels considered safe (per US Title 21 CFR 361.1) or below 3000 mrem.
- •Any condition which, in the opinion of the Investigator and/or Sponsor, would jeopardize participant safety or compliance with the Protocol.
研究组 & 干预措施
Drug: varegacestat
Single oral dose of varegacestat administered on study Day 1
干预措施: varegacestat (Drug)
结局指标
主要结局
The mass balance of varegacestat following administration of a single oral dose (containing ~100 µCi) [14C]varegacestat in healthy adult male participants.
时间窗: Up to 15 days
次要结局
- The area under the concentration equivalent-time curve (AUC), from time 0 to the last observed non-zero concentration of varegacesatat and AL102-MTB (Varegacestat metabolite) in plasma.(Up to 15 days)
- The total radioactivity in plasma, whole blood, urine, and feces following administration of a single oral dose (containing ~100 µCi) [14C]varegacestat in healthy adult male participants.(Up to 15 days)
- The AUC from time 0 extrapolated to infinity, calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant of varegacesatat and AL102-MTB in plasma.(Up to 15 days)
- Apparent first-order terminal elimination half-life (t1/2) will be calculated as 0.693/Kel of varegacesatat and AL102-MTB (Varegacestat metabolite) in plasma.(Up to 15 days)
- Maximum observed concentration (Cmax) of varegacesatat and AL102-MTB (Varegacestat metabolite) in plasma.(Up to 15 days)
- Percentage of each metabolite in urine and feces relative to the administered dose or percentage of metabolites in plasma relative to total drug related exposure AUC.(Up to 15 days)
- The safety and tolerability of a single oral dose (containing ~100 µCi) [14C]varegacestat in healthy adult male participants by incidences of treatment-emergent adverse events.(Up to 15 days)