A Phase 1, Open-label, Two-cohort, Single Dose Study to Assess the Mass Balance, Route of Elimination, and Metabolic Profile of [14C] Labeled CRN00808 and Absolute Bioavailability of CRN00808 in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Mass balance of CRN00808
研究概览
简要总结
A phase 1 healthy volunteer study to assess the mass balance, elimination, and metabolic profile of CRN00808. The study will be conducted in 2 parts: Part A, to characterize the absorption, distribution, metabolism, excretion, and mass balance of orally administered radio-labeled CRN00808; Part B, to determine the absolute bioavailability of CRN00808 administered using CRN00808 and radio-labeled CRN00808 as intravenous and oral forms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Male subjects 19 to 55 years of age
- •BMI 18 to 30 kg/m2
排除标准
- •Any uncontrolled or active major systemic disease including, but not limited to: acromegaly (with or without pituitary surgery or radiation therapy), cardiac, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential
- •History or presence of malignancy within the past 5 years. Subjects who have been successfully treated (for 3 months or longer) with no recurrence of basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled.
- •Use of any investigational drug within the past 60 days or 5 half-lives, whichever is longer
- •Have a medically significant abnormality observed during screening or the admission physical examination or in any other baseline measurements
- •Use of any prior medication without approval of the investigator within 14 days prior to admission
- •Tested positive at screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result
- •History of alcohol or substance abuse in the past 6 months
- •Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this Phase 1 study
研究组 & 干预措施
Part A: [14C]-CRN00808 Oral Solution
Single oral dose of CRN00808 containing [14C]-CRN00808
干预措施: [14C]-CRN00808 (Drug)
Part B: CRN00808 Oral Capsule w/ [14C]-CRN00808 IV microtracer
Single oral dose of CRN00808 followed by [14C]-CRN00808 IV microtracer injection
干预措施: [14C]-CRN00808 (Drug)
Part B: CRN00808 Oral Capsule w/ [14C]-CRN00808 IV microtracer
Single oral dose of CRN00808 followed by [14C]-CRN00808 IV microtracer injection
干预措施: CRN00808 (Drug)
结局指标
主要结局
Mass balance of CRN00808
时间窗: Up to 21 days (until >90% of dose is recovered)
Total radioactivity in urine and feces following a single oral dose \[14C\]-CRN00808 (expressed as a percentage of the total radioactive dose administered)
Absolute bioavailability of CRN00808
时间窗: 5 days
Absolute bioavailability is calculated from the areas under the curve of intravenous and oral administration
次要结局
- Pharmacokinetics (t1/2)(Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7)
- Pharmacokinetics (Tmax)(Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7)
- Pharmacokinetics (AUC)(Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7)
- Pharmacokinetics (CL)(Day 1 through to Day 7)
- Pharmacokinetics (Vz/F)(Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7)
- Pharmacokinetics (CL/F)(Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7)
- Pharmacokinetics (Vz)(Day 1 through to Day 7)