NCT04990310已完成1 期
An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-CORT113176 in Healthy Male 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 Dose of [14C]-CORT113176
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]-CORT113176 in healthy male 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
- •Willing and able to participate in the whole study
- •Have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day)
- •Provide written informed consent
- •Adhere to the contraception requirements.
排除标准
- •Have received any investigational medicine in a clinical research study within 90 days
- •Are, or are immediate family members of, a study site or sponsor employee
- •Evidence of current severe acute respiratory syndrome (SARS-CoV-2) infection
- •History of any drug or alcohol abuse, or regularly consume >21 units alcohol per week
- •Current smoker or user of e-cigarettes and nicotine replacement products within the last 6 months
- •Have pregnant or lactating partners
- •Radiation exposure, exceeding 5 milliSieverts (mSv) in the last 12 months or 10 mSv in the last 5 years
- •Clinically significant abnormal results of clinical chemistry, hematology or urinalysis as judged by the investigator
- •Confirmed positive drugs of abuse test result
- •Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
- •Active renal and/or hepatic disease
- •History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal (GI) disease, neurological or psychiatric disorder
- •Any form of cancer within the last 5 years (exceptions apply)
- •History and/or symptoms of adrenal insufficiency
- •Condition that could be aggravated by glucocorticoid antagonism or activation
- •Donation of blood or plasma 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 herbal remedies (other than up to 4 g of paracetamol per day) within 14 days. COVID-19 vaccines are accepted concomitant medications. Exceptions may apply on a case by case basis.
- •Currently using glucocorticoids or have a history of systemic glucocorticoid use at any dose within the last 12 months or 3 months for inhaled products
- •Additional criteria apply.
研究组 & 干预措施
Study Participants
Experimental
On Day 1, participants will receive a single oral dose of [14C]-CORT113176 450 mg (3 X 150 mg lipid formulation capsules) in the fed state.
干预措施: [14C]-CORT113176 (Drug)
结局指标
主要结局
Mass Balance Recovery in Excreta After a Single Dose of [14C]-CORT113176
时间窗: Until the mass balance criteria for all participants have been met (estimated up to 28 days)
次要结局
- Plasma PK of Total Radioactivity after Oral Dosing: Time from Dosing to Cmax (Tmax)(Before dosing and at pre-specified time points up to Day 8 after dosing)
- Mass Balance Recovery in Feces After a Single Oral Dose of [14C]-CORT113176(Until the mass balance criteria for all participants have been met (estimated up to 28 days))
- Plasma PK of CORT113176 after Oral Dosing: Tmax(Before dosing and at pre-specified time points up to Day 8 after dosing)
- Mass Balance Recovery in Urine After a Single Oral Dose of [14C]-CORT113176(Until the mass balance criteria for all participants have been met (estimated up to 28 days))
- Number of CORT113176 Metabolites Accounting for ≥10% of Total Circulating Radioactivity or ≥10% of Dose Excreted in Urine and Feces(Until the mass balance criteria for all participants have been met (estimated up to 28 days))
- Plasma Pharmacokinetics (PK) of Total Radioactivity after Oral Dosing: Peak Plasma Concentration (Cmax)(Before dosing 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)(Before dosing 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)(Before dosing and at pre-specified time points up to Day 8 after dosing)
- Plasma PK of CORT113176 after Oral Dosing: Cmax(Before dosing and at pre-specified time points up to Day 8 after dosing)
- Plasma PK of CORT113176 after Oral Dosing: AUC0-last(Before dosing and at pre-specified time points up to Day 8 after dosing)
- Plasma PK of CORT113176 after Oral Dosing: t1/2(Before dosing and at pre-specified time points up to Day 8 after dosing)
- Distribution of Total Radioactivity into Red Blood Cells after Oral Dosing(Before dosing and at pre-specified time points up to Day 8 after dosing)
- Number of Participants with One or More Adverse Events(Until the mass balance criteria for all participants have been met (estimated up to 28 days))
研究者
研究点 (1)
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