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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8507-006 | Other Identifier | MSD |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]Ulonivirine | Experimental | All participants receive a single oral dose of [14C]ulonivirine on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]Ulonivirine | Drug | Oral Solution |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. | At designated timepoints (up to approximately 5 weeks postdose) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 5 weeks |
| Number of Participants Who Discontinue the Study Due to an AE |
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Key Inclusion Criteria include but are not limited to:
Key Exclusion Criteria include but are not limited to:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortea CRU Madison (Site 002) | Madison | Wisconsin | 53704 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| 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. |
| 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. | 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. | 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. | 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. | At approximately 1 week postdose |
| Plasma Ulonivirine: Terminal Half-life (t1/2) | Plasma samples will be collected to determine the t1/2 of ulonivirine. | 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. | 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) | 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. | 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. | 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. | 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. | At approximately 1 week postdose |
| Plasma Total Radioactivity: t1/2 | Plasma samples will be collected to determine the t1/2 of total radioactivity. | 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. | 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. | 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. | 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. | At designated timepoints (up to approximately 5 weeks postdose) |
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. |
| Up to approximately 5 weeks |