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

ConditionHealthy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMerck Sharp & Dohme LLC

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Rosuvastatin

    Drug

    Oral tablet

  • MK-4646

    Drug

    Oral capsule

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: Treatment A: RosuvastatinActive comparator 1 intervention
Group B: Treatment B: Rosuvastatin + MK-4646Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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)
2

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

1

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
2

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.

Time frame
Up to approximately 9 days
3

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)
4

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)

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: