Healthy
Conditions
Brief summary
Researchers are looking for new treatments for people living with HIV-1 (Human Immunodeficiency Virus Type 1). HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system. MK-4646 is a trial medicine designed to treat HIV-1. Before giving a trial medicine to people with a health condition, researchers first do studies in healthy participants. The goals of this trial are to learn: * What happens to rosuvastatin in a participant's body over time when it is taken with MK-4646 * About the safety of MK-4646 when taken with rosuvastatin and if people tolerate it. Tolerate means participants will receive trial medicine in the trial unless they need to stop it due to health problems.
Interventions
DRUGRosuvastatin
Oral tablet
DRUGMK-4646
Oral capsule
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Is in good health before randomization * Has a body mass index (BMI) between 18 and 32 kg/m\^2, inclusive
Exclusion criteria
* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases * Has a history of cancer (malignancy) * Has a history or presence of myopathy or rhabdomyolysis (with or without prior statin therapy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the AUC0-Inf of rosuvastatin when MK-4646 is coadministered with rosuvastatin. |
| Maximum Plasma Concentration (Cmax) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the Cmax of rosuvastatin when MK-4646 is coadministered with rosuvastatin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 26 days | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported. |
| Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 9 days | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported. |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the AUC0-last of rosuvastatin when MK-4646 is coadministered with rosuvastatin. |
| Area Under the Concentration-Time Curve from Time 0 to 24 (AUC0-24) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the AUC0-24 of rosuvastatin when MK-4646 is coadministered with rosuvastatin. |
| Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the Tmax of rosuvastatin when MK-4646 is coadministered with rosuvastatin. |
| Apparent Terminal Half-life (t½) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the t½ of rosuvastatin when MK-4646 is coadministered with rosuvastatin. |
| Apparent Clearance (CL/F) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the CL/F of rosuvastatin when MK-4646 is coadministered with rosuvastatin. |
| Apparent Volume of Distribution (Vz/F) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the Vz/F of rosuvastatin when MK-4646 is coadministered with rosuvastatin. |
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed