About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Has an estimated glomerular filtration rate (eGFR) < 30 mL/min), but is not on hemodialysis (HD)

Has ESRD maintained on stable outpatient regimen of intermittent high-flux HD at a healthcare center for > 3 months prior to study entry

Disqualifiers

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.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

MK-2828
Drug
Oral administration

Treatment groups

24 Participants

are divided into 3 treatment groups

Group A: Severe Renal ImpairmentExperimental treatment 1 intervention

Group B: End Stage Renal Disease (ESRD) on Hemodialysis (HD)Experimental treatment 1 intervention

Group C: Healthy Mean Matched ControlExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

2

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

3

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

4

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

Secondary outcomes

1

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

2

Number of Participants Who Discontinue Study Intervention Due to an 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 2 days

3

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

Time frame

Prior to hemodialysis (HD) and at designated time points until day 6

4

Area Under the Concentration-time Curve Determined from the Pre-dialyzer Line (AUCCa) of MK-2828

Blood samples will be collected to determine the during AUCCa of MK-2828 during the dialysis period

Time frame

Prior to hemodialysis (HD) and at designated time points until day 6

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts