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OpenTrials
Completed

NCT Number: NCT07334886

A Study of [14C]Ulonivirine ([14C]MK-8507) in Healthy Adults (MK-8507-006)

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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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Fortea CRU Madison (Site 002)

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[14C]Ulonivirine

Drug

Oral Solution

Other names: [14C]ULO, [14C]MK-8507

Primary outcomes

  1. Cumulative Percentage of Total Radioactivity Recovered (FE) from Urine and Feces

    Time frame: 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.

  2. FE from Urine

    Time frame: At designated timepoints (up to approximately 5 weeks postdose)

    Urine samples will be collected to determine the percent of total radioactivity recovered from urine.

  3. FE from Feces

    Time frame: At designated timepoints (up to approximately 5 weeks postdose)

    Fecal samples will be collected to determine the percent of total radioactivity recovered from feces.

  4. Cumulative Amount of Radioactivity Recovered from Urine

    Time frame: At designated timepoints (up to approximately 5 weeks postdose)

    Urine samples will be collected to determine the cumulative amount of radioactivity recovered from urine.

  5. Percent of Total Radioactive Dose Recovered from Urine

    Time frame: 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.

  6. Cumulative Amount of Radioactivity Recovered from Feces

    Time frame: At designated timepoints (up to approximately 5 weeks postdose)

    Fecal samples will be collected to determine the cumulative amount of radioactivity recovered from feces.

  7. Percent of Total Radioactive Dose Recovered from Feces

    Time frame: 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.

  8. Plasma Ulonivirine: Area Under the Concentration-Time Curve from Time 0 to Time of the Last Concentration (AUC0-last)

    Time frame: At designated timepoints (up to approximately 2 weeks postdose)

    Plasma samples will be collected to determine the AUC0-last of ulonivirine.

  9. Plasma Ulonivirine: Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf)

    Time frame: At designated timepoints (up to approximately 2 weeks postdose)

    Plasma samples will be collected to determine the AUC0-inf of ulonivirine.

  10. Plasma Ulonivirine: Maximum Observed Concentration (Cmax)

    Time frame: At designated timepoints (up to approximately 2 weeks postdose)

    Plasma samples will be collected to determine the Cmax of ulonivirine.

  11. Plasma Ulonivirine: Concentration at 168 Hours Postdose (C168)

    Time frame: At approximately 1 week postdose

    Plasma samples will be collected to determine the C168 of ulonivirine.

  12. Plasma Ulonivirine: Terminal Half-life (t1/2)

    Time frame: At designated timepoints (up to approximately 2 weeks postdose)

    Plasma samples will be collected to determine the t1/2 of ulonivirine.

  13. Plasma Ulonivirine: Time of Maximum Observed Concentration (Tmax)

    Time frame: At designated timepoints (up to approximately 2 weeks postdose)

    Plasma samples will be collected to determine the Tmax of ulonivirine.

  14. 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 samples will be collected to determine the ratio of ulonivirine to total plasma radioactivity: AUC0-last (ulonivirine)/ AUC0-last (total radioactivity)

  15. Plasma Total Radioactivity: AUC0-last

    Time frame: At designated timepoints (up to approximately 5 weeks postdose)

    Plasma samples will be collected to determine the AUC0-last of total radioactivity.

  16. Plasma Total Radioactivity: AUC0-inf

    Time frame: At designated timepoints (up to approximately 5 weeks postdose)

    Plasma samples will be collected to determine the AUC0-inf of total radioactivity.

  17. Plasma Total Radioactivity: Cmax

    Time frame: At designated timepoints (up to approximately 5 weeks postdose)

    Plasma samples will be collected to determine the Cmax of total radioactivity.

  18. Plasma Total Radioactivity: C168

    Time frame: At approximately 1 week postdose

    Plasma samples will be collected to determine the C168 of total radioactivity.

  19. Plasma Total Radioactivity: t1/2

    Time frame: At designated timepoints (up to approximately 5 weeks postdose)

    Plasma samples will be collected to determine the t1/2 of total radioactivity.

  20. Plasma Total Radioactivity: Tmax

    Time frame: At designated timepoints (up to approximately 5 weeks postdose)

    Plasma samples will be collected to determine the Tmax of total radioactivity.

  21. Total Number of Metabolites in Plasma that Represent at least 10% of the Dose of Radioactivity

    Time frame: 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.

  22. Total Number of Metabolites in Urine that Represent at least 10% of the Dose of Radioactivity

    Time frame: 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.

  23. Total Number of Metabolites in Feces that Represent at least 10% of the Dose of Radioactivity

    Time frame: 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.

Secondary outcomes

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: 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.

  2. Number of Participants Who Discontinue the Study Due to an AE

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Study to Investigate the Absorption, Metabolism, and Excretion of [14C]Ulonivirine in Healthy Adults

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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