About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Is in good health before randomization
Has a body mass index (BMI) between 18 and 32 kg/m², inclusive
Disqualifiers
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)
Trial design
Crossover
Treatments tested in this trial
Rosuvastatin
DrugOral tablet
MK-4646
DrugOral capsule
Treatment groups
Trial outcomes
Primary outcomes
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin
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
Blood samples will be collected to determine the Cmax of rosuvastatin when MK-4646 is coadministered with rosuvastatin.
Secondary outcomes
Number of Participants Who Experience an Adverse Event (AE)
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
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
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
Blood samples will be collected to determine the AUC0-24 of rosuvastatin when MK-4646 is coadministered with rosuvastatin.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: