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OpenTrials
Completed

NCT Number: NCT07530289

A Clinical Study of Ulonivirine (MK-8507) With Atorvastatin and Metformin in Healthy Adults (MK-8507-018)

Researchers want to learn about ulonivirine when given with atorvastatin and metformin in healthy people. The goal of this study is to compare the amount of atorvastatin and metformin in a person's body over time when given with and without ulonivirine.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion ( Site 0001)

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Has body mass index (BMI) 18.0 and ≤ 32.0 kg/m^2
  • Is medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and electrocardiogram (ECG)

Exclusion criteria

  • Has history of cancer (malignancy)
  • Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)

Treatment and study plan

atorvastatin

Drug

Oral tablet

metformin

Drug

Oral tablet

Ulonivirine

Drug

Oral tablet

Other names: MK-8507

Primary outcomes

  1. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Atorvastatin

    Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose

    Blood samples will be collected at multiple time points to determine the AUC0-inf of atorvastatin

  2. AUC0-inf of Metformin

    Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose

    Blood samples will be collected at multiple time points to determine the AUC0-inf of metformin

Secondary outcomes

  1. Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Atorvastatin

    Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose

    Blood samples will be collected at multiple time points to determine the AUC0-last of atorvastatin

  2. Maximum Plasma Concentration (Cmax) of Atorvastatin

    Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose

    Blood samples will be collected at multiple time points to determine the Cmax of atorvastatin

  3. Plasma Concentration at 24 Hours (C24) of Atorvastatin

    Time frame: 24 hours post-dose

    Blood samples will be collected to estimate the C24 of atorvastatin

  4. Time to Maximum Plasma Concentration (Tmax) of Atorvastatin

    Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose

    Blood samples will be collected at multiple time points to estimate the Tmax of atorvastatin

  5. Apparent Terminal Half-life (t1/2) of Atorvastatin

    Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose

    Blood samples will be collected at multiple time points to estimate the t1/2 of atorvastatin

  6. AUC0-last of Atorvastatin Metabolite (2-OH Atorvastatin)

    Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose

    Blood samples will be collected at multiple time points to determine the AUC0-last of 2-OH atorvastatin

  7. AUC0-inf of 2-OH Atorvastatin

    Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose

    Blood samples will be collected at multiple time points to determine the AUC0-inf of 2-OH atorvastatin

  8. Cmax of 2-OH Atorvastatin

    Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose

    Blood samples will be collected at multiple time points to determine the Cmax of 2-OH atorvastatin

  9. C24 of 2-OH Atorvastatin

    Time frame: 24 hours post-dose

    Blood samples will be collected to estimate the C24 of 2-OH atorvastatin

  10. Tmax of 2-OH Atorvastatin

    Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose

    Blood samples will be collected at multiple time points to estimate the Tmax of 2-OH atorvastatin

  11. t1/2 of 2-OH Atorvastatin

    Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose

    Blood samples will be collected at multiple time points to estimate the t1/2 of 2-OH atorvastatin

  12. AUC0-last of Atorvastatin Metabolite (4-OH Atorvastatin)

    Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose

    Blood samples will be collected at multiple time points to determine the AUC0-last of 4-OH atorvastatin

  13. AUC0-inf of 4-OH Atorvastatin

    Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose

    Blood samples will be collected at multiple time points to determine the AUC0-inf of 4-OH atorvastatin

  14. Cmax of 4-OH Atorvastatin

    Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose

    Blood samples will be collected at multiple time points to determine the Cmax of 4-OH atorvastatin

  15. C24 of 4-OH Atorvastatin

    Time frame: 24 hours post-dose

    Blood samples will be collected to estimate the C24 of 4-OH atorvastatin

  16. Tmax of 4-OH Atorvastatin

    Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose

    Blood samples will be collected at multiple time points to estimate the Tmax of 4-OH atorvastatin

  17. t1/2 of 4-OH Atorvastatin

    Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose

    Blood samples will be collected at multiple time points to estimate the t1/2 of 4-OH atorvastatin

  18. AUC0-last of Metformin

    Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose

    Blood samples will be collected at multiple time points to determine the AUC0-last of metformin

  19. Cmax of Metformin

    Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose

    Blood samples will be collected at multiple time points to determine the Cmax of metformin

  20. C24 of Metformin

    Time frame: 24 hours post-dose

    Blood samples will be collected to estimate the C24 of metformin

  21. Tmax of Metformin

    Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose

    Blood samples will be collected at multiple time points to estimate the Tmax of metformin

  22. t1/2 of Metformin

    Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose

    Blood samples will be collected at multiple time points to estimate the t1/2 of metformin

  23. Number of Participants Who Experience One or More Adverse Events (AEs)

    Time frame: Up to approximately 21 days after first dose

    An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The number of participants who experience an AE will be reported.

  24. Number of Participants Who Discontinue Study Intervention Due to an AE

    Time frame: Up to approximately 7 days after first dose

    An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. The number of participants who discontinue study treatment due to an AE will be reported.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 1, Open-Label, Two-Period Fixed Sequence Study to Evaluate the Effects of a Single Oral Dose of Ulonivirine (MK-8507) on the Single-Dose Pharmacokinetics of Atorvastatin and Metformin in Healthy Adult Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2026
Registry last updated
Jun 15, 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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