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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Metformin; Drug: Ulonivirine; Drug: Atorvastatin

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion ( Site 0001)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atorvastatin + metformin + ulonivirine; In Period 1, participants will receive atorvastatin and metformin. In Period 2, participants will receive atorvastatin, metformin, and ulonivirine.	Drug: Metformin; Oral tablet; Drug: Ulonivirine; Oral tablet; Other Names: MK-8507; Drug: Atorvastatin; Oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-inf of Metformin	Blood samples will be collected at multiple time points to determine the AUC0-inf of metformin	Day 1: Predose and at designated timepoints up to 72 hours post-dose
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Atorvastatin	Blood samples will be collected at multiple time points to determine the AUC0-inf of atorvastatin	Day 1: Predose and at designated timepoints up to 72 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Atorvastatin	Blood samples will be collected at multiple time points to determine the AUC0-last of atorvastatin	Day 1: Predose and at designated timepoints up to 72 hours post-dose
Maximum Plasma Concentration (Cmax) of Atorvastatin	Blood samples will be collected at multiple time points to determine the Cmax of atorvastatin	Day 1: Predose and at designated timepoints up to 72 hours post-dose
Plasma Concentration at 24 Hours (C24) of Atorvastatin	Blood samples will be collected to estimate the C24 of atorvastatin	24 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of Atorvastatin	Blood samples will be collected at multiple time points to estimate the Tmax of atorvastatin	Day 1: Predose and at designated timepoints up to 72 hours post-dose
Apparent Terminal Half-life (t1/2) of Atorvastatin	Blood samples will be collected at multiple time points to estimate the t1/2 of atorvastatin	Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-last of Atorvastatin Metabolite (2-OH Atorvastatin)	Blood samples will be collected at multiple time points to determine the AUC0-last of 2-OH atorvastatin	Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-inf of 2-OH Atorvastatin	Blood samples will be collected at multiple time points to determine the AUC0-inf of 2-OH atorvastatin	Day 1: Predose and at designated timepoints up to 72 hours post-dose
Cmax of 2-OH Atorvastatin	Blood samples will be collected at multiple time points to determine the Cmax of 2-OH atorvastatin	Day 1: Predose and at designated timepoints up to 72 hours post-dose
C24 of 2-OH Atorvastatin	Blood samples will be collected to estimate the C24 of 2-OH atorvastatin	24 hours post-dose
Tmax of 2-OH Atorvastatin	Blood samples will be collected at multiple time points to estimate the Tmax of 2-OH atorvastatin	Day 1: Predose and at designated timepoints up to 72 hours post-dose
t1/2 of 2-OH Atorvastatin	Blood samples will be collected at multiple time points to estimate the t1/2 of 2-OH atorvastatin	Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-last of Atorvastatin Metabolite (4-OH Atorvastatin)	Blood samples will be collected at multiple time points to determine the AUC0-last of 4-OH atorvastatin	Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-inf of 4-OH Atorvastatin	Blood samples will be collected at multiple time points to determine the AUC0-inf of 4-OH atorvastatin	Day 1: Predose and at designated timepoints up to 72 hours post-dose
Cmax of 4-OH Atorvastatin	Blood samples will be collected at multiple time points to determine the Cmax of 4-OH atorvastatin	Day 1: Predose and at designated timepoints up to 72 hours post-dose
C24 of 4-OH Atorvastatin	Blood samples will be collected to estimate the C24 of 4-OH atorvastatin	24 hours post-dose
Tmax of 4-OH Atorvastatin	Blood samples will be collected at multiple time points to estimate the Tmax of 4-OH atorvastatin	Day 1: Predose and at designated timepoints up to 72 hours post-dose
t1/2 of 4-OH Atorvastatin	Blood samples will be collected at multiple time points to estimate the t1/2 of 4-OH atorvastatin	Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-last of Metformin	Blood samples will be collected at multiple time points to determine the AUC0-last of metformin	Day 1: Predose and at designated timepoints up to 72 hours post-dose
Cmax of Metformin	Blood samples will be collected at multiple time points to determine the Cmax of metformin	Day 1: Predose and at designated timepoints up to 72 hours post-dose
C24 of Metformin	Blood samples will be collected to estimate the C24 of metformin	24 hours post-dose
Tmax of Metformin	Blood samples will be collected at multiple time points to estimate the Tmax of metformin	Day 1: Predose and at designated timepoints up to 72 hours post-dose
t1/2 of Metformin	Blood samples will be collected at multiple time points to estimate the t1/2 of metformin	Day 1: Predose and at designated timepoints up to 72 hours post-dose
Number of Participants Who Experience One or More Adverse Events (AEs)	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.	Up to approximately 21 days after first dose
Number of Participants Who Discontinue Study Intervention Due to an AE	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.	Up to approximately 7 days after first dose

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2026
• Primary Completion (Estimated): June 3, 2026
• Study Completion (Estimated): June 3, 2026

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Azoles; Pyrroles; Heptanoic Acids; Biguanides; Guanidines; Amidines; Atorvastatin; Metformin; ulonivirine
• Other Study ID Numbers: 8507-018; MK-8507-018 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No