A Phase I, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-AMG 510 Following a Single Oral Dose in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Maximum observed concentration (Cmax)
研究概览
简要总结
The primary objectives of the study are: to characterize the primary route(s) of elimination of [14C]-AMG 510 and drug-related material, and estimate the overall recovery of radiolabeled material in healthy male participants after oral administration of [14C]-AMG 510, and to characterize the pharmacokinetic (PK) of total radioactivity and AMG 510 following a single oral dose of [14C]-AMG 510 in healthy male participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Healthy male participants between 18 and 55 years of age (inclusive) at the time of Screening.
- •In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations as assessed by the Investigator (or designee).
- •Body mass index between 18 and 30 kg/m2 (inclusive) at the time of Screening.
- •History of a minimum of 1 bowel movement per day.
排除标准
- •History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
- •History suggestive of esophageal (including esophageal spasm, esophagitis), gastric, or duodenal ulceration or bowel disease (including but not limited to peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease, or irritable bowel syndrome); or a history of gastrointestinal surgery other than uncomplicated appendectomy.
- •Inability to swallow oral medication or history of malabsorption syndrome.
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
- •Poor peripheral venous access.
- •History of alcoholism or drug/chemical abuse within 1 year prior to Check-in.
- •Participant has received a dose of an investigational drug (new chemical entity) within the past 90 days or 5 half-lives, whichever is longer, prior to Check-in.
- •Participants with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in.
- •Participants who have participated in a radiolabeled drug study where exposures are known to the Investigator within the previous 4 months prior to admission to the clinic for this study or participated in a radiolabeled drug study where exposures are not known to the Investigator within the previous 6 months prior to admission to the clinic for this study. The total 12-month exposure from this study and a maximum of 2 other previous radiolabeled studies within 4 to 12 months prior to this study will be within the Code of Federal Regulations (CFR)-recommended levels considered safe, per US Title 21 CFR 361.1: less than 5000 mrem whole body annual exposure with consideration given to the half-lives of the previous radiolabeled study drugs received.
研究组 & 干预措施
AMG510
Each participant will receive a single oral dose of AMG510 on Day 1 after an overnight fast.
干预措施: AMG 510 (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax)
时间窗: Day 1 to Day 14
Area under the concentration-time curve (AUC) from time zero to infinity (AUCinf)
时间窗: Day 1 to Day 14
AUC from time zero to the last quantifiable concentration (AUClast)
时间窗: Day 1 to Day 14
Plasma AMG 510 to total radioactivity ratio
时间窗: Day 1 to Day 14
Percentage (feu) of AMG510 excreted in urine
时间窗: Day 1 to Day 14
Renal clearance (CLR) of AMG510
时间窗: Day 1 to Day 14
Percentage (fef) of AMG510 excreted in feces
时间窗: Day 1 to Day 14
Time of Cmax (tmax)
时间窗: Day 1 to Day 14
Apparent terminal elimination half-life (t1/2)
时间窗: Day 1 to Day 14
Total clearance (AMG 510 only; CL/F)
时间窗: Day 1 to Day 14
Volume of distribution (AMG 510 only; Vz/F)
时间窗: Day 1 to Day 14
Whole blood to plasma total radioactivity ratio
时间窗: Day 1 to Day 14
Amount (Aeu) of AMG510 excreted in urine
时间窗: Day 1 to Day 14
Amount (Aef) of AMG510 excreted in feces
时间窗: Day 1 to Day 14
次要结局
- QTc interval measured by 12-lead electrocardiogram (ECG)(Up to approximately 6 weeks)
- Metabolite profile of AMG 510(Day 1 to Day 14)
- Identification of AMG 510 metabolites(Day 1 to Day 14)
- Incidence of adverse events(Up to approximately 6 weeks)