A Study to Investigate the Absorption, Metabolism, and Excretion of [14C]Ulonivirine in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Cumulative Percentage of Total Radioactivity Recovered (FE) from Urine and Feces
研究概览
简要总结
The goal of this study is to learn how [14C]ulonivirine moves through a healthy person's body over time. Researchers will study how [14C]ulonivirine is absorbed by the body, broken down by the body, and how it leaves the body.
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
- •include but are not limited to:
- •Is in good health
- •Has a body mass index (BMI) of 18 to 32 kg/m^2
排除标准
- •include but are not limited to:
- •Has a history of cancer
- •Has positive tests for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus antibody
研究组 & 干预措施
[14C]Ulonivirine
All participants receive a single oral dose of [14C]ulonivirine on Day 1.
干预措施: [14C]Ulonivirine (Drug)
结局指标
主要结局
Cumulative Percentage of Total Radioactivity Recovered (FE) from Urine and Feces
时间窗: At designated timepoints (up to approximately 5 weeks postdose)
Urine and fecal samples will be collected to determine the cumulative percentage of radioactivity recovered from both urine and feces.
FE from Urine
时间窗: At designated timepoints (up to approximately 5 weeks postdose)
Urine samples will be collected to determine the percent of total radioactivity recovered from urine.
FE from Feces
时间窗: At designated timepoints (up to approximately 5 weeks postdose)
Fecal samples will be collected to determine the percent of total radioactivity recovered from feces.
Cumulative Amount of Radioactivity Recovered from Urine
时间窗: At designated timepoints (up to approximately 5 weeks postdose)
Urine samples will be collected to determine the cumulative amount of radioactivity recovered from urine.
Percent of Total Radioactive Dose Recovered from Urine
时间窗: At designated timepoints (up to approximately 5 weeks postdose)
Urine samples will be collected to determine the percent of the total radioactive dose recovered from urine.
Cumulative Amount of Radioactivity Recovered from Feces
时间窗: At designated timepoints (up to approximately 5 weeks postdose)
Fecal samples will be collected to determine the cumulative amount of radioactivity recovered from feces.
Percent of Total Radioactive Dose Recovered from Feces
时间窗: At designated timepoints (up to approximately 5 weeks postdose)
Fecal samples will be collected to determine the percent of the total radioactive dose recovered from feces.
Plasma Ulonivirine: Area Under the Concentration-Time Curve from Time 0 to Time of the Last Concentration (AUC0-last)
时间窗: At designated timepoints (up to approximately 2 weeks postdose)
Plasma samples will be collected to determine the AUC0-last of ulonivirine.
Plasma Ulonivirine: Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf)
时间窗: At designated timepoints (up to approximately 2 weeks postdose)
Plasma samples will be collected to determine the AUC0-inf of ulonivirine.
Plasma Ulonivirine: Maximum Observed Concentration (Cmax)
时间窗: At designated timepoints (up to approximately 2 weeks postdose)
Plasma samples will be collected to determine the Cmax of ulonivirine.
Plasma Ulonivirine: Concentration at 168 Hours Postdose (C168)
时间窗: At approximately 1 week postdose
Plasma samples will be collected to determine the C168 of ulonivirine.
Plasma Ulonivirine: Terminal Half-life (t1/2)
时间窗: At designated timepoints (up to approximately 2 weeks postdose)
Plasma samples will be collected to determine the t1/2 of ulonivirine.
Plasma Ulonivirine: Time of Maximum Observed Concentration (Tmax)
时间窗: At designated timepoints (up to approximately 2 weeks postdose)
Plasma samples will be collected to determine the Tmax of ulonivirine.
Ratio of Ulonivirine to Total Plasma Radioactivity: AUC0-last (ulonivirine)/ AUC0-last (total radioactivity)
时间窗: At designated timepoints (up to approximately 5 weeks postdose)
Plasma samples will be collected to determine the ratio of ulonivirine to total plasma radioactivity: AUC0-last (ulonivirine)/ AUC0-last (total radioactivity)
Plasma Total Radioactivity: AUC0-last
时间窗: At designated timepoints (up to approximately 5 weeks postdose)
Plasma samples will be collected to determine the AUC0-last of total radioactivity.
Plasma Total Radioactivity: AUC0-inf
时间窗: At designated timepoints (up to approximately 5 weeks postdose)
Plasma samples will be collected to determine the AUC0-inf of total radioactivity.
Plasma Total Radioactivity: Cmax
时间窗: At designated timepoints (up to approximately 5 weeks postdose)
Plasma samples will be collected to determine the Cmax of total radioactivity.
Plasma Total Radioactivity: C168
时间窗: At approximately 1 week postdose
Plasma samples will be collected to determine the C168 of total radioactivity.
Plasma Total Radioactivity: t1/2
时间窗: At designated timepoints (up to approximately 5 weeks postdose)
Plasma samples will be collected to determine the t1/2 of total radioactivity.
Plasma Total Radioactivity: Tmax
时间窗: At designated timepoints (up to approximately 5 weeks postdose)
Plasma samples will be collected to determine the Tmax of total radioactivity.
Total Number of Metabolites in Plasma that Represent at least 10% of the Dose of Radioactivity
时间窗: At designated timepoints (up to approximately 5 weeks postdose)
Plasma samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.
Total Number of Metabolites in Urine that Represent at least 10% of the Dose of Radioactivity
时间窗: At designated timepoints (up to approximately 5 weeks postdose)
Urine samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.
Total Number of Metabolites in Feces that Represent at least 10% of the Dose of Radioactivity
时间窗: At designated timepoints (up to approximately 5 weeks postdose)
Fecal samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.
次要结局
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 5 weeks)
- Number of Participants Who Discontinue the Study Due to an AE(Up to approximately 5 weeks)