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

NCT07530289 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 8507-018MK-8507-018
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (24)

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

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

• Maximum Plasma Concentration (Cmax) of Atorvastatin

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

• Plasma Concentration at 24 Hours (C24) of Atorvastatin

  24 hours post-dose

• Time to Maximum Plasma Concentration (Tmax) of Atorvastatin

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

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

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

Study Arms (1)

Atorvastatin + metformin + ulonivirine

EXPERIMENTAL

In Period 1, participants will receive atorvastatin and metformin. In Period 2, participants will receive atorvastatin, metformin, and ulonivirine.

Drug: Atorvastatin; Drug: Metformin; Drug: Ulonivirine

Interventions

Metformin DRUG

Oral tablet

Atorvastatin + metformin + ulonivirine

Ulonivirine DRUG

Oral tablet

Also known as: MK-8507

Atorvastatin + metformin + ulonivirine

Atorvastatin DRUG

Oral tablet

Atorvastatin + metformin + ulonivirine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

Atorvastatin; Metformin; ulonivirine

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 15, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 3, 2026
• Study Completion (Estimated): June 17, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share