A Phase 1, Open-label, Study of the Absorption, Metabolism, and Excretion of [14C]-KBP-5074 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
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast)
研究概览
简要总结
This is a Phase 1, open-label, nonrandomized, single-dose mass balance and metabolite identification study in healthy male subjects.
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
- •Males, of any race, between 18 and 55 years of age, inclusive, at screening.
- •Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening.
- •In good health, determined by no clinically significant findings from medical history, physical examination (assessed only at check-in), 12-lead 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).
- •History of a minimum of 1 bowel movement per day.
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, psychiatric, or other disorder, as determined by the investigator (or designee).
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed; cholecystectomy will not be allowed).
- •Positive urine drug screen, including cotinine, at screening; positive alcohol test result or positive urine drug screen, including cotinine, at check-in.
- •Use of any drugs or substances known to be strong or moderate inhibitors or inducers of cytochrome P450 (CYP)3A4 or P-glycoprotein substrates within 30 days prior to study drug administration. Medications will be reviewed by the medical monitor to determine acceptability for the study.
研究组 & 干预措施
[14C]-KBP-5074
干预措施: KBP-5074 (Drug)
结局指标
主要结局
Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast)
时间窗: up to 216 hours postdose
Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) - Plasma
Pharmacokinetic Parameter: Area under the concentration-time curve from time 0 to infinity (AUC0-∞)
时间窗: up to 216 hours postdose
Area under the concentration-time curve from time 0 to infinity (AUC0-∞) - Plasma
Pharmacokinetic Parameter: Time of the maximum observed concentration (Cmax)
时间窗: up to 216 hours postdose
Time of the maximum observed concentration (Cmax) - Plasma
Mass Balance of KBP-5074
时间窗: up to 240 hours postdose
Percentage of total radioactivity recovered in urine and feces following a single dose \[14C\]-KBP-5074
次要结局
- Metabolite radioprofiling and identification in plasma, urine and feces(up to 240 hours postdose)