Healthy
Conditions
Brief summary
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.
Interventions
DRUG[14C]Ulonivirine
Oral Solution
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria include but are not limited to: * Is in good health * Has a body mass index (BMI) of 18 to 32 kg/m\^2 Key
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Metabolites in Feces that Represent at least 10% of the Dose of Radioactivity | 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. |
| Total Number of Metabolites in Plasma that Represent at least 10% of the Dose of Radioactivity | 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 | 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. |
| Plasma Total Radioactivity: Cmax | At designated timepoints (up to approximately 5 weeks postdose) | Plasma samples will be collected to determine the Cmax of total radioactivity. |
| Plasma Total Radioactivity: AUC0-inf | At designated timepoints (up to approximately 5 weeks postdose) | Plasma samples will be collected to determine the AUC0-inf of total radioactivity. |
| Ratio of Ulonivirine to Total Plasma Radioactivity: AUC0-last (ulonivirine)/ AUC0-last (total radioactivity) | 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) |
| Cumulative Percentage of Total Radioactivity Recovered (FE) from Urine and Feces | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | At approximately 1 week postdose | Plasma samples will be collected to determine the C168 of ulonivirine. |
| Plasma Ulonivirine: Terminal Half-life (t1/2) | 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) | At designated timepoints (up to approximately 2 weeks postdose) | Plasma samples will be collected to determine the Tmax of ulonivirine. |
| Plasma Total Radioactivity: AUC0-last | 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: C168 | At approximately 1 week postdose | Plasma samples will be collected to determine the C168 of total radioactivity. |
| Plasma Total Radioactivity: t1/2 | 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 | At designated timepoints (up to approximately 5 weeks postdose) | Plasma samples will be collected to determine the Tmax of total radioactivity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Discontinue the Study Due to an AE | Up to approximately 5 weeks | 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. |
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 5 weeks | 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. |
Countries
United States
Outcome results
None listed