A Phase 1, Open-Label, Mass Balance Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of 14C-TERN-701 Following Administration of a Single Oral Dose in Healthy Adult Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Percentage of Total Amount of [14C]-Radiolabel Excreted into Urine per Sampling Interval (Aeurine,14C,t1-t2)
研究概览
简要总结
The goal of the study is to learn what happens to different forms of TERN-701 medications in a healthy person's body over time. Researchers will compare what happens to different forms of TERN-701 in a person's body over time.
The goal of the study is to learn:
- What happens to different forms of TERN-701 in a person's body over time.
- The amount and number of different forms of TERN-701 that leave a person's body over time.
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
- •The main inclusion criteria include but are not limited to the following:
- •Has body mass index (BMI) ≥18.5 and ≤32.0 kg/m^2
- •Is in good health
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Has history or presence of any medical condition or prior surgery that may impact typical absorption, distribution, metabolism, or excretion of the orally administered study drug (e.g., gastric bypass, gastrointestinal dysmotility, irritable or inflammatory bowel disease)
- •Has history or laboratory evidence of hyperthyroidism (thyroid-stimulating hormone [TSH] < lower limit of normal [LLN]) or hypothyroidism (TSH ≥8 mIU/L)
- •Has history of cancer that has not been in complete remission for > 5 years (except basal cell skin cancer or squamous cell skin cancer with a history of curative treatment and no recurrence for > 1 year prior)
- •Has history of dysphagia, aspiration, or other conditions that could potentially impede the ability to safely orally ingest the study drug per protocol
- •Has history of incomplete bladder emptying with voiding (i.e., urinary retention) or recent history of awakening more than once at night to void
- •Has usual habit of < 1 or > 3 bowel movements per day
- •Has family history of long QT syndrome or of unexplained sudden death in a first-degree relative under 50 years of age
- •Has documented congenital or acquired long QT syndrome
研究组 & 干预措施
[14C]-TERN-701
Participants receive a single oral dose of radiolabeled TERN-701 ([14C]-TERN-701) on Day 1.
干预措施: TERN-701 (Drug)
结局指标
主要结局
Percentage of Total Amount of [14C]-Radiolabel Excreted into Urine per Sampling Interval (Aeurine,14C,t1-t2)
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Urine will be collected to determine the Aeurine,14C,t1-t2 of radiolabeled \[14C\]-TERN-701.
Cumulative Percentage of Total Amount of [14C]-Radiolabel Excreted into Urine up to the Last Sampling Interval (Aeurine,14C)
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Urine will be collected to determine the Aeurine,14C of radiolabeled \[14C\]-TERN-701.
Percentage of Total Amount of [14C]-Radiolabel Excreted into Feces per Sampling Interval (Aefeces,14C,t1-t2)
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Feces will be collected to determine the Aefeces,14C,t1-t2 of radiolabeled \[14C\]-TERN-701.
Cumulative Percentage of Total Amount of [14C]-Radiolabel Excreted into Feces Up to the Last Sampling Interval (Aefeces,14C)
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Feces will be collected to determine the Aefeces,14C of radiolabeled \[14C\]-TERN-701.
Percentage of Total Amount of [14C]-Radiolabel Excreted from Body per Sampling Interval (Aetotal, 14C, t1-t2)
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Urine and Feces will be collected to determine the Aetotal,14C,t1-t2 of radiolabeled \[14C\]-TERN-701.
Cumulative Percentage of Total Excretion of [14C]-Radiolabel from the Body (Aetotal, 14C)
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Urine and Feces will be collected to determine the Aetotal,14C of radiolabeled \[14C\]-TERN-701. Calculated as, Aetotal,14C= Aeurine,14C +Aefeces,14C.
Maximum Concentration Observed in Plasma (Cmax) of TERN-701 in Plasma
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the Cmax of TERN-701.
Time to Maximum Concentration Observed in Plasma (Tmax) of TERN-701 in Plasma
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the Tmax of TERN-701.
Apparent Terminal Half-Life (t1/2) of TERN-701 in Plasma
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the t1/2 of TERN-701.
Area Under the Concentration-Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-last) of TERN-701 in Plasma
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the AUC0-Last of TERN-701.
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-Inf) of TERN-701 in Plasma
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the AUC0-inf of TERN-701.
Apparent Oral Clearance (CL/F) of TERN-701 in Plasma
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the CL/F of TERN-701.
Apparent Volume of Distribution (Vz/F) of TERN-701 in Plasma
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the Vz/F of TERN-701.
Total [14C]-Radiolabel in Plasma
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the Total \[14C\]-Radiolabel, calculated as the AUCinf of non-radiolabeled TERN-701 in plasma divided by the AUCinf of total \[14C\]-radiolabel in plasma.
Tmax of Total [14C]-Radiolabel in Plasma
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the Tmax of radiolabeled \[14C\]-TERN-701.
t1/2 of Total [14C]-Radiolabel in Plasma
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the t1/2 of radiolabeled \[14C\]-TERN-701.
AUC0-last of Total [14C]-Radiolabel in Plasma
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the AUC0-last of radiolabeled \[14C\]-TERN-701.
AUC0-Inf of Total [14C]-Radiolabel in Plasma
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the AUC0-Inf of radiolabeled \[14C\]-TERN-701.
Cmax of Total [14C]-Radiolabel in Plasma
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the Cmax of radiolabeled \[14C\]-TERN-701.
Tmax of Total [14C]-Radiolabel in Whole Blood
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the Tmax of radiolabeled \[14C\]-TERN-701.
t1/2 of Total [14C]-Radiolabel in Whole Blood
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the t1/2 of radiolabeled \[14C\]-TERN-701.
AUC0-last of Total [14C]-Radiolabel in Whole Blood
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the AUC0-last of radiolabeled \[14C\]-TERN-701.
AUC0-Inf of Total [14C]-Radiolabel in Whole Blood
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the AUC0-Inf of radiolabeled \[14C\]-TERN-701.
Cmax of Total [14C]-Radiolabel in Whole Blood
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the Cmax of radiolabeled \[14C\]-TERN-701.
Cumulative Amount of Total [14C]-Radiolabel Excreted in Urine (Aeurine)
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Urine samples will be collected to determine the Aeurine of radiolabeled \[14C\]-TERN-701.
Renal Clearence (CLr) of [14C] radioactivity
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Urine samples will be collected to determine the CLr of radiolabeled \[14C\]-TERN-701.
Percent of Dose Excreted as Radioactivity in Urine (%Feurine) of [14C] radioactivity
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Urine samples will be collected to determine the %Feurine of radiolabeled \[14C\]-TERN-701.
Cumulative Amount of Total [14C]-Radiolabel Excreted in Feces (Aefeces) of [14C] radioactivity
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Feces samples will be collected to determine the Aefeces of radiolabeled \[14C\]-TERN-701.
Percent of Dose Excreted as Radioactivity in Feces (%Fefeces) of [14C] radioactivity
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Feces samples will be collected to determine the %Fefeces of radiolabeled \[14C\]-TERN-701.
Percentage Area Under the Concentration-Time Curve (AUC) of [14C]-Radiolabel TERN-701 Metabolite in Plasma
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Blood samples will be collected to determine the Percentage of AUC of \[14C\]-radiolabel TERN-701 metabolite in plasma.
Percentage of Administered Dose of [14C]-Radiolabel TERN-701 Metabolite in Feces
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Feces samples will be collected to determine the percentage of administered dose of \[14C\]-radiolabel TERN-701 metabolite in feces.
Percentage of the [14C]-Radiolabel TERN-701 Metabolite in Urine
时间窗: Pre-dose and at designated time points up to 408 hours post dose
Urine samples will be collected to determine the percentage of \[14C\]-radiolabel TERN-701 metabolite in urine.
次要结局
- Mean concentration of [14C]-TERN-701 Elimination(Pre-dose and at designated time points up to 408 hours post dose)
- Rate of Elimination of [14C]-TERN-701(Pre-dose and at designated time points up to 408 hours post dose)
- Whole Blood to Plasma Total [14C]-Radiolabel AUC Ratio(Pre-dose and at designated time points up to 408 hours post dose)
- Number of TERN-701 Metabolite in ≥10% of Total Exposure of [14C]-Radiolabel in Plasma(Pre-dose and at designated time points up to 408 hours post dose)
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 49 days)
- Number of Participants Who Discontinue Study Due to an AE(Up to approximately 18 days)