A Clinical Study of MK-1084 in Participants With Renal Impairment (MK-1084-010)

Launched by MERCK SHARP & DOHME LLC · Feb 3, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "A Clinical Study of MK-1084 in Participants With Renal Impairment," aims to understand how the medication MK-1084 behaves in the bodies of people with kidney issues. Researchers will compare the levels of MK-1084 in individuals with moderate to severe kidney impairment (when kidneys don’t function as they should) to those who are healthy. The study will also assess the safety of MK-1084 for people with kidney problems and whether they can tolerate it well.

To participate in this trial, individuals must be between 18 and 75 years old and have a specific body weight range. Those with moderate or severe kidney impairment need to have stable kidney function and should not have needed dialysis in the past year. On the other hand, healthy participants must be in good overall health. Participants will be closely monitored during the study, and important health checks will be performed. This trial is not yet recruiting participants, but it represents an important step in understanding how MK-1084 can be safely used in people with kidney issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• The main inclusion criteria include but are not limited to the following:
• All participants:
• • - Has a BMI ≥18.0 and ≤40.0 kg/m\^2
• Participants with severe or moderate RI:
• • With the exception of RI, is sufficiently healthy for study participation
• • Has stable renal function with no clinically significant change in renal status at least 29 days prior to dosing and is not currently or has not been previously on dialysis for at least 1 year
• Participants with normal renal function:
• • - Is medically healthy
• Exclusion Criteria:
• The main exclusion criteria include but are not limited to the following:
• All participants:
• • Has a history of cancer (malignancy)
• • Has positive results for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus
• • Has had major surgery and/or donated or lost significant volume of blood within 56 days prior to dosing
• Participants with severe or moderate RI:
• • Has a history or presence of renal artery stenosis
• • Has a renal transplant or nephrectomy