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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
Oral Solution
Fortea CRU Madison (Site 002)
Madison, Wisconsin, United States
Cumulative Percentage of Total Radioactivity Recovered (FE) from Urine and Feces
Urine and fecal samples will be collected to determine the cumulative percentage of radioactivity recovered from both urine and feces.
Time frame: At designated timepoints (up to approximately 5 weeks postdose)
FE from Urine
Urine samples will be collected to determine the percent of total radioactivity recovered from urine.
Time frame: At designated timepoints (up to approximately 5 weeks postdose)
FE from Feces
Fecal samples will be collected to determine the percent of total radioactivity recovered from feces.
Time frame: At designated timepoints (up to approximately 5 weeks postdose)
Cumulative Amount of Radioactivity Recovered from Urine
Urine samples will be collected to determine the cumulative amount of radioactivity recovered from urine.
Time frame: At designated timepoints (up to approximately 5 weeks postdose)
Percent of Total Radioactive Dose Recovered from Urine
Urine samples will be collected to determine the percent of the total radioactive dose recovered from urine.
Time frame: At designated timepoints (up to approximately 5 weeks postdose)
Cumulative Amount of Radioactivity Recovered from Feces
Fecal samples will be collected to determine the cumulative amount of radioactivity recovered from feces.
Time frame: At designated timepoints (up to approximately 5 weeks postdose)
Percent of Total Radioactive Dose Recovered from Feces
Fecal samples will be collected to determine the percent of the total radioactive dose recovered from feces.
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Time frame: At designated timepoints (up to approximately 5 weeks postdose)
Plasma Ulonivirine: Area Under the Concentration-Time Curve from Time 0 to Time of the Last Concentration (AUC0-last)
Plasma samples will be collected to determine the AUC0-last of ulonivirine.
Time frame: At designated timepoints (up to approximately 2 weeks postdose)
Plasma Ulonivirine: Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf)
Plasma samples will be collected to determine the AUC0-inf of ulonivirine.
Time frame: At designated timepoints (up to approximately 2 weeks postdose)
Plasma Ulonivirine: Maximum Observed Concentration (Cmax)
Plasma samples will be collected to determine the Cmax of ulonivirine.
Time frame: At designated timepoints (up to approximately 2 weeks postdose)
Plasma Ulonivirine: Concentration at 168 Hours Postdose (C168)
Plasma samples will be collected to determine the C168 of ulonivirine.
Time frame: At approximately 1 week postdose
Plasma Ulonivirine: Terminal Half-life (t1/2)
Plasma samples will be collected to determine the t1/2 of ulonivirine.
Time frame: At designated timepoints (up to approximately 2 weeks postdose)
Plasma Ulonivirine: Time of Maximum Observed Concentration (Tmax)
Plasma samples will be collected to determine the Tmax of ulonivirine.
Time frame: At designated timepoints (up to approximately 2 weeks postdose)
Ratio of Ulonivirine to Total Plasma Radioactivity: AUC0-last (ulonivirine)/ AUC0-last (total radioactivity)
Plasma samples will be collected to determine the ratio of ulonivirine to total plasma radioactivity: AUC0-last (ulonivirine)/ AUC0-last (total radioactivity)
Time frame: At designated timepoints (up to approximately 5 weeks postdose)
Plasma Total Radioactivity: AUC0-last
Plasma samples will be collected to determine the AUC0-last of total radioactivity.
Time frame: At designated timepoints (up to approximately 5 weeks postdose)
Plasma Total Radioactivity: AUC0-inf
Plasma samples will be collected to determine the AUC0-inf of total radioactivity.
Time frame: At designated timepoints (up to approximately 5 weeks postdose)
Plasma Total Radioactivity: Cmax
Plasma samples will be collected to determine the Cmax of total radioactivity.
Time frame: At designated timepoints (up to approximately 5 weeks postdose)
Plasma Total Radioactivity: C168
Plasma samples will be collected to determine the C168 of total radioactivity.
Time frame: At approximately 1 week postdose
Plasma Total Radioactivity: t1/2
Plasma samples will be collected to determine the t1/2 of total radioactivity.
Time frame: At designated timepoints (up to approximately 5 weeks postdose)
Plasma Total Radioactivity: Tmax
Plasma samples will be collected to determine the Tmax of total radioactivity.
Time frame: At designated timepoints (up to approximately 5 weeks postdose)
Total Number of Metabolites in Plasma that Represent at least 10% of the Dose of Radioactivity
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.
Time frame: At designated timepoints (up to approximately 5 weeks postdose)
Total Number of Metabolites in Urine that Represent at least 10% of the Dose of Radioactivity
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.
Time frame: At designated timepoints (up to approximately 5 weeks postdose)
Total Number of Metabolites in Feces that Represent at least 10% of the Dose of Radioactivity
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.
Time frame: At designated timepoints (up to approximately 5 weeks postdose)
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Time frame: Up to approximately 5 weeks
Number of Participants Who Discontinue the Study Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Time frame: Up to approximately 5 weeks