MK-2828
DrugOral administration
NCT Number: NCT07348237
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.
Interested in participating?
Request Info24 year–85 year
All sexes
Interventional
Phase 1
Floridian Clinical Research ( Site 0001), Miami Lakes, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
The main inclusion criteria include but are not limited to the following:
Severe Renal Impairment Participants:
ESRD on HD Participants:
The main exclusion criteria include but are not limited to the following:
Renal Impairment Participants:
Healthy Matched Control Participants:
Oral administration
Time frame: Pre dose and at designated time points up to 192 hours post dose
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
Blood samples will be collected to determine the AUC0-last of MK-2828
Time frame: Pre dose and at designated time points up to 24 hours post dose
Blood samples will be collected to determine the AUC0-24 of MK-2828
Time frame: Pre dose and at designated time points up to 192 hours post dose
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
Blood samples will be collected to determine the Tmax of MK-2828
Time frame: At designated time points up to 24 hours post dose
Blood samples will be collected to determine the C24 of MK-2828
Time frame: Pre dose and at designated time points up to 192 hours post dose
Blood samples will be collected to determine the t1/2 of MK-2828
Time frame: Pre dose and at designated time points up to 192 hours post dose
Blood samples will be collected to determine the CL/F of MK-2828
Time frame: Pre dose and at designated time points up to 192 hours post dose
Blood samples will be collected to determine the Vz/F of MK-2828
Time frame: Up to approximately 14 days
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
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: Prior to hemodialysis (HD) and at designated time points until day 6
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
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
Blood samples will be collected to determine the during AUCCv of MK-2828 during the dialysis period
Time frame: Prior to hemodialysis (HD) and at designated time points until day 6
Blood samples will be collected to determine the CLD of MK-2828 based on plasma during the dialysis period
Time frame: Prior to hemodialysis (HD) and at designated time points until day 6
Blood samples will be collected to determine the ER_D of MK-2828 during the dialysis period
Contact information is provided by the study sponsor or research team.
Merck Sharp & Dohme LLC
Industry
An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of MK-2828 in Participants With Renal Impairment
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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