NCT07364214已完成1 期
A Phase 1, Open-Label Study to Characterize the Metabolism, Excretion, and Mass Balance of a Single Intravenous Dose of 100 mg Containing 75 µCi of [14C]-Quemliclustat in Healthy Adult Male Participants
干预措施
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
- Percentage of total radioactivity excreted in urine and feces
研究概览
简要总结
The purpose of the study is to investigate the routes of elimination and overall mass balance of 100 mg quemliclustat containing 75 μCi [14C] following a single IV infusion of [14C]-quemliclustat in healthy adult male participants, and to quantify total radioactivity (TRA) in plasma, whole blood, urine, and feces.
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
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, standard vital signs, and ECGs, as deemed by the PI or designee.
- •Participants must follow protocol-specified contraception guidance.
- •Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the start of infusion based on participant self-reporting.
- •BMI ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.
- •Understands the study procedures in the Informed Consent Form and is willing and able to comply with the protocol.
排除标准
- •Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- •History or presence of clinically significant medical, surgical, or psychiatric condition or disease in the opinion of the PI or designee.
- •History of any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the participant by their participation in the study.
- •History or presence of alcohol or drug abuse within the past 2 years prior to the start of infusion.
- •History of presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Quemliclustat
Experimental
Participants will receive a single dose of [14C]-quemliclustat through IV infusion.
干预措施: Quemliclustat (Drug)
结局指标
主要结局
Percentage of total radioactivity excreted in urine and feces
时间窗: Up to 40 days
Total radioactivity in blood
时间窗: Up to 40 days
Total radioactivity in plasma
时间窗: Up to 40 days
Excretion of total radioactivity in urine
时间窗: Up to 40 days
Excretion of total radioactivity in feces
时间窗: Up to 40 days
次要结局
- Number of Participants with Treatment Emergent Adverse Events (TEAEs)(Up to 54 days)
- Area Under the Curve From 0 to Last Observed Non-zero Concentration (AUC [0-Last]) for quemliclustat(Up to 40 days)
- Area Under the Curve From Time '0' Extrapolated to Infinity (AUC[0-inf]) for quemliclustat(Up to 40 days)
- Maximum Observed Plasma Concentration (Cmax) for quemliclustat(Up to 40 days)
- Elimination Half-life (t1/2) for quemliclustat(Up to 40 days)
- Excretion of quemliclustat in urine(Up to 40 days)
研究者
研究点 (1)
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