A Phase 1 interventional study of Atorvastatin and Metformin in Healthy, sponsored by Merck Sharp & Dohme LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Basic science
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.
Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Oral tablet
Oral tablet
Oral tablet
Also known as: MK-8507
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
Time frame: 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
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 hours post-dose
Tmax of Metformin
Blood samples will be collected at multiple time points to estimate the Tmax of metformin
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 7 days after first dose
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC