A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Brensocatib Following a Single Oral Administration in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Area Under the Concentration Time Curve (AUC) of Brensocatib in Plasma
研究概览
简要总结
The primary purpose of the study is to determine the mass balance of total radioactivity and the routes of elimination by quantifying the urinary and fecal excretion of radioactivity following a single oral administration of [14C]-brensocatib, to characterize the pharmacokinetics (PK) of brensocatib in plasma and urine, PK of total radioactivity in plasma, whole blood, urine and to determine the blood-to-plasma ratios of total radioactivity.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 18.0 and 32.0 kilograms per square meter (kg/m^2), inclusive, at screening.
- •In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in as assessed by the investigator (or designee).
排除标准
- •Positive hepatitis panel and/or positive human immunodeficiency virus test. Results consistent with previous vaccination to Hepatitis B are not exclusionary.
- •Administration of a coronavirus disease 2019 (COVID-19) vaccine in the past 14 days prior to dosing.
- •Poor peripheral venous access.
- •Have previously completed or withdrawn from this study or any other study investigating brensocatib, and have previously received brensocatib. Known allergy to brensocatib or any of the excipients used in the formulation.
- •Exposure to significant diagnostic or therapeutic radiation (e.g., 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.
- •Participated in more than 3 radiolabeled drug studies in the last 12 months (previous study to be at least 4 months prior to check-in to the study site where exposures are known to the investigator or 6 months prior to check-in to the study site for a radiolabeled drug study where exposures are not known to the investigator).
- •Note: Other inclusion/exclusion criteria may apply.
研究组 & 干预措施
[14C]-brensocatib
Healthy participants will receive single oral dose of [14C]-brensocatib on Day 1 under fasted conditions.
干预措施: [14C]-brensocatib (Drug)
结局指标
主要结局
Area Under the Concentration Time Curve (AUC) of Brensocatib in Plasma
时间窗: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Pharmacokinetics of brensocatib following a single dose in healthy participants will be assessed.
AUC∞ Plasma Brensocatib/Plasma Total Radioactivity Ratio Calculated as AUC∞ of Plasma Brensocatib Relative to AUC∞ of Plasma Total Radioactivity
时间窗: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
AUC∞ Blood/Plasma Total Radioactivity Ratio Calculated as AUC∞ of Whole Blood Total Radioactivity to AUC∞ of Plasma Total Radioactivity
时间窗: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Amount Excreted in Urine (Aeu) of Brensocatib
时间窗: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Total Radioactivity Expressed as Amount of [14C]-brensocatib Excreted in Urine
时间窗: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Total Radioactivity Expressed as Amount of [14C]-brensocatib Excreted in Feces (Aef)
时间窗: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
次要结局
- AUC of Brensocatib Metabolites in Plasma(Pre-dose and at multiple timepoints post-dose on Days 1 to 9)
- Number of Participants Who Experienced at Least one Adverse Event (AE)(Up to Day 14)