NCT03877952已完成1 期
A Phase 1 Open-label, Single-dose Study Designed to Assess the Mass Balance Recovery and Metabolite Profile and to Identify Metabolite Structures for [14C]-CORT125281 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Mass Balance Recovery in Excreta After a Single Oral Dose of 14C-CORT125281
研究概览
简要总结
This study will evaluate the mass balance recovery and metabolite profile, and will identify metabolite structures following a single oral dose of 14C-CORT125281 in healthy 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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index 18.0 to 30.0 kg/m^2, inclusive
- •Provide written informed consent
- •Have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day)
- •Able to swallow capsules
- •Adhere to specified contraception requirements.
排除标准
- •Have received any investigational medicine in a clinical research study within the previous 3 months, or CORT125281 at any time
- •Have a pregnant partner
- •Employees or immediate family members of employees of the study site or Sponsor
- •History of abuse of any drug or alcohol, or regularly consume more than 21 units alcohol/week
- •Smokers or users of e-cigarettes and nicotine replacement products within the last 6 months
- •Occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017; greater than background radiation exposure from other sources exceeding 5 milliSieverts (mSv) in the last 12 months or 10 mSv in the last 5 years
- •Clinically significant abnormal results of clinical laboratory safety tests, electrocardiogram, or measurement of heart rate and blood pressure
- •History of clinically significant cardiovascular, renal, hepatic, respiratory or gastrointestinal disease, neurological or psychiatric disorder
- •History and/or symptoms of adrenal insufficiency or any condition that could be aggravated by glucocorticoid blockade (e.g., an autoimmune disease; allergy requiring treatment)
- •Donation or loss of greater than 400 mL of blood within the previous 3 months
- •Are taking, or have taken, any prescribed or over-the-counter drug or vitamins/herbal remedies within 1 week (longer restrictions apply for some medicines).
- •NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
研究组 & 干预措施
Study Participants
Experimental
On Day 1, participants will receive a single oral dose of 14C-CORT125281 360 mg (6 X 60 mg capsules) after an overnight fast.
干预措施: 14C-CORT125281 (Drug)
结局指标
主要结局
Mass Balance Recovery in Excreta After a Single Oral Dose of 14C-CORT125281
时间窗: Until the mass balance criteria for all participants have been met (estimated up to 10 days)
次要结局
- Plasma PK of Total Radioactivity after Oral Dosing: Mean Residence Time (MRT)(Pre-dose and at pre-specified time points up to Day 8 after dosing)
- Mass Balance Recovery in Urine After a Single Oral Dose of 14C-CORT125281(Until the mass balance criteria for all participants have been met (estimated up to 10 days))
- Plasma Pharmacokinetics (PK) of Total Radioactivity after Oral Dosing: Peak Plasma Concentration (Cmax)(Pre-dose and at pre-specified time points up to Day 8 after dosing)
- Plasma PK of Total Radioactivity after Oral Dosing: Area Under the Plasma Concentration-time Curve from Zero Time to Time of the Last Measurable Concentration (AUC0-last)(Pre-dose and at pre-specified time points up to Day 8 after dosing)
- Plasma PK of Total Radioactivity after Oral Dosing: Apparent Elimination Half-life (t1/2)(Pre-dose and at pre-specified time points up to Day 8 after dosing)
- Plasma PK of CORT125281 after Oral Dosing: tmax(Pre-dose and at pre-specified time points up to Day 8 after dosing)
- Plasma PK of CORT125281 after Oral Dosing: AUC0-last(Pre-dose and at pre-specified time points up to Day 8 after dosing)
- Plasma PK of CORT125281 after Oral Dosing: t1/2(Pre-dose and at pre-specified time points up to Day 8 after dosing)
- Plasma PK of CORT125281 after Oral Dosing: MRT(Pre-dose and at pre-specified time points up to Day 8 after dosing)
- Distribution of Total Radioactivity into Red Blood Cells after Oral Dosing(Pre-dose and at pre-specified time points up to Day 8 after dosing)
- Plasma PK of Total Radioactivity after Oral Dosing: Time from Dosing to Cmax (tmax)(Pre-dose and at pre-specified time points up to Day 8 after dosing)
- Mass Balance Recovery in Feces After a Single Oral Dose of 14C-CORT125281(Until the mass balance criteria for all participants have been met (estimated up to 10 days))
- Plasma PK of CORT125281 after Oral Dosing: Cmax(Pre-dose and at pre-specified time points up to Day 8 after dosing)
- Number of CORT125281 Metabolites Accounting for ≥10% of Total Radioactivity Detected in Plasma, Urine, and Feces(Until the mass balance criteria for all participants have been met (estimated up to 10 days))
- Percentage of Participants with One or More Adverse Events(Until the mass balance criteria for all participants have been met (estimated up to 10 days))
研究者
研究点 (1)
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