Healthy
Conditions
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.
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Atorvastatin | 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 |
| AUC0-inf of Metformin | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Blood samples will be collected at multiple time points to determine the AUC0-last of atorvastatin |
| Maximum Plasma Concentration (Cmax) of Atorvastatin | 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 |
| Plasma Concentration at 24 Hours (C24) of Atorvastatin | 24 hours post-dose | Blood samples will be collected to estimate the C24 of atorvastatin |
| Time to Maximum Plasma Concentration (Tmax) of Atorvastatin | 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 |
| Apparent Terminal Half-life (t1/2) of Atorvastatin | 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 |
| AUC0-last of Atorvastatin Metabolite (2-OH Atorvastatin) | 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 |
| AUC0-inf of 2-OH Atorvastatin | 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 |
| Cmax of 2-OH Atorvastatin | 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 |
| C24 of 2-OH Atorvastatin | 24 hours post-dose | Blood samples will be collected to estimate the C24 of 2-OH atorvastatin |
| Tmax of 2-OH Atorvastatin | 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 |
| t1/2 of 2-OH Atorvastatin | 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 |
| AUC0-last of Atorvastatin Metabolite (4-OH Atorvastatin) | 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 |
| AUC0-inf of 4-OH Atorvastatin | 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 |
| Cmax of 4-OH Atorvastatin | 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 |
| C24 of 4-OH Atorvastatin | 24 hours post-dose | Blood samples will be collected to estimate the C24 of 4-OH atorvastatin |
| Tmax of 4-OH Atorvastatin | 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 |
| t1/2 of 4-OH Atorvastatin | 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 |
| AUC0-last of Metformin | 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 |
| Cmax of Metformin | 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 |
| C24 of Metformin | 24 hours post-dose | Blood samples will be collected to estimate the C24 of metformin |
| Tmax of Metformin | 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 |
| t1/2 of Metformin | 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 |
| Number of Participants Who Experience One or More Adverse Events (AEs) | 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. |
| Number of Participants Who Discontinue Study Intervention Due to an AE | 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. |
Countries
United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed