A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Fosgonimeton (ATH-1017) Following a Single Subcutaneous Dose in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Mass balance of total radioactivity from [14C]-Fosgonimeton
研究概览
简要总结
This is a Phase 1, open-label, nonrandomized, single-dose human, absorption, metabolism, and excretion study of [14C]-Fosgonimeton
详细描述
This is a Phase 1, open-label, nonrandomized, single-dose study, designed to evaluate the absorption, metabolism, and excretion of [14C]-Fosgonimeton. Healthy male subjects will receive a single subcutaneous dose of [14C]-Fosgonimeton.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males, of any race, between 18 and 60 years of age, inclusive.
- •Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- •In good health, determined by the investigator's discretion
- •Subjects and their partners will agree to use contraception during their participation
- •History of a minimum of 1 bowel movement per day.
排除标准
- •Significant history or clinical manifestation of any relevant, significant medical disorder, as determined by the investigator (or designee).
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
- •Positive hepatitis panel and/or positive human immunodeficiency virus test.
- •Use or intend to use any prescription medications/products within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee).
- •Use or intend to use any nonprescription medications within 7 days prior to check-in, unless deemed acceptable by the investigator (or designee).
- •Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known) prior to dosing.
- •Subjects who have participated in more than 3 radiolabeled drug studies in the last 12 months
- •Poor peripheral venous access.
- •Subjects with exposure to significant diagnostic or therapeutic radiation (e.g., serial x-ray, computed tomography scan, barium meal)
研究组 & 干预措施
Dosing Group
All 8 subjects will receive a single dose of study drug
干预措施: [14C]-Fosgonimeton (Drug)
结局指标
主要结局
Mass balance of total radioactivity from [14C]-Fosgonimeton
时间窗: Samples collected up to 9 days post-dose.
Total radioactivity recovery (fet1-t2)
Area under the plasma concentration time curve (AUC) for of ATH-1017/ATH-1001
时间窗: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
AUC will be determined from plasma samples.
Routes/rates of elimination of [14C]-Fosgonimeton
时间窗: Samples collected up to 9 days post-dose.
Total radioactivity recovery (fet1-t2) through routes of elimination (urine and feces).
Maximum observed plasma concentration (Cmax) of ATH-1017/ATH-1001
时间窗: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
Cmax will be determined from plasma samples.
Time to maximum observed plasma concentration (Tmax) of ATH-1017/ATH-1001
时间窗: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
Tmax will be determined from plasma samples
Half-life (t1/2) of ATH-1017/ATH-1001
时间窗: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
t1/2 will be determined from plasma samples.
次要结局
- Quantitative metabolite profiles in plasma, urine, and feces after [14C]-Fosgonimeton administration(Samples collected pre-dose and at predetermined timepoints up to 9 days post-dose)
- The chemical structure of major metabolites in plasma, urine, and feces after [14C]-Fosgonimeton administration(Samples collected pre-dose and at predetermined timepoints up to 9 days post-dose)
- Incidence and severity of adverse events (safety and tolerability) of [14C]-Fosgonimeton when administered to healthy subjects(Samples collected pre-dose and at predetermined timepoints up to 17 days post-dose)