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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8507-018 | Other Identifier | MSD |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin + metformin + ulonivirine | Experimental | In Period 1, participants will receive atorvastatin and metformin. In Period 2, participants will receive atorvastatin, metformin, and ulonivirine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | Oral tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion ( Site 0001) | Tempe | Arizona | 85283 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D008687 | Metformin |
| C000723084 | ulonivirine |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Metformin |
| Drug |
Oral tablet |
|
| Ulonivirine | Drug | Oral tablet |
|
|
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 |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |