A Clinical Trial to Evaluate the Effects of MK-4646 on Rosuvastatin in Healthy Participants (MK-4646-007)

Phase 1Not Yet RecruitingNCT07785830

Merck Sharp & Dohme LLC16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

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.

Time frame: At designated timepoints (up to approximately 72 hours post dose)

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.

Time frame: At designated timepoints (up to approximately 72 hours post dose)

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.

Time frame: Up to approximately 26 days

Number of Participants Who Discontinue Study Treatment Due to an AE

Time frame: Up to approximately 9 days

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.

Time frame: At designated timepoints (up to approximately 72 hours post dose)

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.

Time frame: At designated timepoints (up to approximately 72 hours post dose)

Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin

Blood samples will be collected to determine the Tmax of rosuvastatin when MK-4646 is coadministered with rosuvastatin.

Time frame: At designated timepoints (up to approximately 72 hours post dose)

Apparent Terminal Half-life (t½) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin

Blood samples will be collected to determine the t½ of rosuvastatin when MK-4646 is coadministered with rosuvastatin.

Time frame: At designated timepoints (up to approximately 72 hours post dose)

Apparent Clearance (CL/F) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin

Blood samples will be collected to determine the CL/F of rosuvastatin when MK-4646 is coadministered with rosuvastatin.

Time frame: At designated timepoints (up to approximately 72 hours post dose)

Apparent Volume of Distribution (Vz/F) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin

Blood samples will be collected to determine the Vz/F of rosuvastatin when MK-4646 is coadministered with rosuvastatin.

Time frame: At designated timepoints (up to approximately 72 hours post dose)