A Clinical Trial of MK-2828 in People With Kidney Disease (MK-2828-006)

Merck Sharp & Dohme LLC18 enrolled

Overview

The goal of this trial is to measure what happens to 1 or 2 doses of MK-2828 in a person's body over time (pharmacokinetic or PK trial). Researchers want to learn if the PK of people with certain types of kidney disease is similar to the PK of healthy people.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Kidney Failure End-Stage Renal Disease Renal Impairment

Interventions

MK-2828DRUG

Oral administration

Eligibility

Sex: ALLMin age: 24 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

The main inclusion criteria include but are not limited to the following: * Is in generally good health, with the exception of renal impairment participants. Participants with stable, chronic medical or psychiatric conditions may be included at the discretion of the investigator and the Sponsor. Severe Renal Impairment Participants: * Has an estimated glomerular filtration rate (eGFR) \< 30 mL/min), but is not on hemodialysis (HD) ESRD on HD Participants: * Has ESRD maintained on stable outpatient regimen of intermittent high-flux HD at a healthcare center for \> 3 months prior to study entry The main exclusion criteria include but are not limited to the following: Renal Impairment Participants: * History of any illness, other than renal impairment, that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study. Healthy Matched Control Participants: * History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. Participants with a remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma) may be enrolled in the study at the discretion of the investigator.

Locations (3)

Panax Clinical Research ( Site 0003)

Miami Lakes, Florida, United States

Floridian Clinical Research ( Site 0001)

Miami Lakes, Florida, United States

Orlando Clinical Research Center ( Site 0002)

Orlando, Florida, United States

Outcomes

Primary Outcomes

Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of MK-2828 in Plasma

Blood samples will be collected to determine the AUC0-inf of MK-2828

Time frame: Pre dose and at designated time points up to 192 hours post dose

Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of MK-2828 in Plasma

Blood samples will be collected to determine the AUC0-last of MK-2828

Time frame: Pre dose and at designated time points up to 192 hours post dose

Area Under the Concentration-time Curve From Time 0 to 24 Hours Postdose (AUC0-24) of MK-2828 in Plasma

Blood samples will be collected to determine the AUC0-24 of MK-2828

Time frame: Pre dose and at designated time points up to 24 hours post dose

Maximum Plasma Concentration (Cmax) of MK-2828 in Plasma

Blood samples will be collected to determine the Cmax of MK-2828

Time frame: Pre dose and at designated time points up to 192 hours post dose

Time of the Maximum Observed Concentration (Tmax) of MK-2828 in Plasma

Blood samples will be collected to determine the Tmax of MK-2828

Time frame: Pre dose and at designated time points up to 192 hours post dose

Concentration at 24 Hours Postdose (C24) of MK-2828 in Plasma

Blood samples will be collected to determine the C24 of MK-2828

Time frame: At designated time points up to 24 hours post dose

Apparent Terminal Elimination Half-life (t1/2) of MK-2828 in Plasma

Blood samples will be collected to determine the t1/2 of MK-2828

Data from ClinicalTrials.gov

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Secondary Outcomes

Number of Participants Who Experience an Adverse Event (AE)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

Time frame: Up to approximately 14 days

Number of Participants Who Discontinue Study Intervention Due to an AE

Time frame: Up to approximately 2 days

Area Under the Concentration-time Curve From Start to End of Dialysis (AUCD) of MK-2828

Blood samples will be collected to determine the AUCD of MK-2828