Ulonivirine taken with atorvastatin and metformin in healthy adults
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
This study tests whether taking ulonivirine changes how much atorvastatin and metformin stay in the body of healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 1 site (Tempe, Arizona) |
| Trial ID | NCT07530289 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional study enrolls healthy adult volunteers to measure drug levels when atorvastatin and metformin are given with and without ulonivirine. Participants will receive the study drugs under controlled conditions and have blood samples taken over time to compare concentrations and pharmacokinetics. Safety monitoring including labs and ECGs will be performed during the study period. Results will clarify whether coadministration alters exposure to the commonly used drugs atorvastatin and metformin.
Who should consider this trial
Good fit: Healthy adults with a body mass index between 18.0 and 32.0 kg/m2 who have no significant medical history and test negative for HIV, hepatitis B, and hepatitis C.
Not a fit: People with a history of cancer, positive HIV/HBV/HCV tests, significant medical conditions, or those on chronic medications are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, this could help doctors know whether dose changes are needed when patients take ulonivirine with atorvastatin or metformin.
How similar studies have performed: Drug–drug interaction studies like this have guided dosing for other antiviral and chronic medications, but specific interaction data for ulonivirine with atorvastatin and metformin are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Tempe, Arizona
- Celerion ( Site 0001) — Tempe, Arizona, United States (Recruiting)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.