A Clinical Study of MK-8527 in Healthy Participants (MK-8527-021)

Phase 1Active Not RecruitingNCT07661108

Merck Sharp & Dohme LLC44 enrolled

Overview

Researchers are studying a medicine called MK-8527 to learn how it behaves in the body of healthy adults. The goal of this study is to learn about the effect of MK-8527 when it is taken with food or with other medicines. Researchers also want to learn about the safety of MK-8527 and if people tolerate it. Tolerate means participants will receive treatment 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

MK-8527DRUG

Oral tablet

ProbenecidDRUG

Oral tablet

ItraconazoleDRUG

Oral solution

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Be in good health * Has a body mass index (BMI) between 18 and 32 kg/m\^2, inclusive Exclusion Criteria: * Has an estimated glomerular filtration rate (eGFR) ≤90 mL/min/1.73 m\^2 * 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 stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed) * Has a history of cancer (malignancy) * Is taking any medication that contains emtricitabine (FTC) or lamivudine (3TC)

Locations (1)

Fortrea Clinical Research Unit Inc ( Site 0001)

Daytona Beach, Florida, United States

Outcomes

Primary Outcomes

Part 1: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma With and Without Food

Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.

Time frame: Predose and at designated timepoints (up to 336 hours postdose)

Part 2: AUC0-inf of MK-8527 in Plasma With and Without Probenecid

Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.

Time frame: Predose and at designated timepoints (up to 336 hours postdose)

Part 3: AUC0-inf of MK-8527 in Plasma With and Without Itraconazole

Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.

Time frame: Predose and at designated timepoints (up to 336 hours postdose)

Secondary Outcomes

Part 1: Area Under the Concentration Time Curve From Time 0 to 336 Hours (AUC0-336) of MK-8527 in Plasma With and Without Food

Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma.

Time frame: Predose and at designated timepoints (up to 336 hours postdose)

Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-8527 in Plasma With and Without Food

Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.

Time frame: Predose and at designated timepoints (up to 336 hours postdose)

Part 1: Maximum Plasma Concentration (Cmax) of MK-8527 in Plasma With and Without Food

Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.

Time frame: Predose and at designated timepoints (up to 336 hours postdose)

Data from ClinicalTrials.gov

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Part 1: Apparent Terminal Half-life (t1/2) of MK-8527 in Plasma With and Without Food

Blood samples will be collected to estimate the apparent terminal t1/2 of MK-8527 in plasma.

Time frame: Predose and at designated timepoints (up to 336 hours postdose)

Part 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 AE will be reported.

Time frame: Up to approximately 43 days

Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE

Time frame: Up to approximately 43 days

Part 2: AUC0-336 of MK-8527 in Plasma With and Without Probenecid

Blood samples will be collected to estimate the AUC0-336 of MK-8527 in plasma.

Time frame: Predose and at designated timepoints (up to 336 hours postdose)

Part 2: Tmax of MK-8527 in Plasma with and without Probenecid

Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.

Time frame: Predose and at designated timepoints (up to 336 hours postdose)

Part 2: Cmax of MK-8527 in Plasma With and Without Probenecid

Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.

Time frame: Predose and at designated timepoints (up to 336 hours postdose)

Part 2: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Probenecid

Blood samples will be collected to estimate the apparent terminal t1/2 of MK-8527 in plasma.

Time frame: Predose and at designated timepoints (up to 336 hours postdose)

Part 2: Urine Concentration at 72 Hours of MK-8527

Urine samples will be collected to estimate the urine concentration of MK-8527.

Time frame: At designated timepoints (up to 72 hours postdose)

Part 2: Renal Clearance of MK-8527

Urine samples will be collected to estimate the renal clearance of MK-8527.

Time frame: At designated timepoints (up to 72 hours postdose)

Part 2: Number of Participants Who Experience an AE

Time frame: Up to approximately 43 days

Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE

Time frame: Up to approximately 43 days

Part 3: AUC0-336 of MK-8527 in Plasma With and Without Itraconazole

Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma.

Time frame: Predose and at designated timepoints (up to 336 hours postdose)

Part 3: Tmax of MK-8527 in Plasma With and Without Itraconazole

Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.

Time frame: Predose and at designated timepoints (up to 336 hours postdose)

Part 3: Cmax of MK-8527 in Plasma With and Without Itraconazole

Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.

Time frame: Predose and at designated timepoints (up to 336 hours postdose)

Part 3: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Itraconazole

Blood samples will be collected to estimate the apparent t1/2 of MK-8527 in plasma.

Time frame: Predose and at designated timepoints (up to 336 hours postdose)

Part 3: Urine Concentration at 72 Hours of MK-8527

Urine samples will be collected to estimate the urine concentration of MK-8527.

Time frame: At designated timepoints (up to 72 hours postdose)

Part 3: Renal Clearance of MK-8527

Urine samples will be collected to estimate the renal clearance of MK-8527.

Time frame: At designated timepoints (up to 72 hours postdose)

Part 3: Number of Participants Who Experience an AE

Time frame: Up to approximately 43 days

Part 3: Number of Participants Who Discontinue Study Treatment Due to an AE

Time frame: Up to approximately 43 days