Clinical trial NCT06814119: A Clinical Study of MK-1084 in Participants With Renal Impairment (MK-1084-010)
Official title: A Clinical Study to Evaluate the Effect of Renal Impairment on the Single-Dose Pharmacokinetics of MK-1084
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Renal Impairment
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to learn what happens to MK-1084 levels in a person's body over time. Researchers will measure what happens to MK-1084 levels in the body when it is given to people with moderate or severe renal impairment (RI) (meaning the kidneys do not work properly) as compared to people who are in good health. Researchers also want to learn about the safety of MK-1084 when it is given to people with RI and if people with RI can tolerate it.


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

Primary outcomes:
measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-1084
timeFrame: At designated timepoints (up to approximately 2 days postdose)
measure: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of MK-1084
timeFrame: At designated timepoints (up to approximately 2 days postdose)
measure: Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24) of MK-1084
timeFrame: At designated timepoints (up to 24 hours postdose)
measure: Plasma Concentration of MK-1084 at 24 Hours Postdose (C24)
timeFrame: At designated timepoints (up to 24 hours postdose)
measure: Maximum Plasma Concentration (Cmax) of MK-1084
timeFrame: At designated timepoints (up to approximately 2 days postdose)
measure: Time to Maximum Plasma Concentration (Tmax) of MK-1084
timeFrame: At designated timepoints (up to approximately 2 days postdose)
measure: Apparent Terminal Half-life (t1/2) of MK-1084
timeFrame: At designated timepoints (up to approximately 2 days postdose)
measure: Apparent Clearance (CL/F) of MK-1084
timeFrame: At designated timepoints (up to approximately 2 days postdose)
measure: Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-1084
timeFrame: At designated timepoints (up to approximately 2 days postdose)
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event
timeFrame: Up to approximately 2 weeks
measure: Number of Participants Who Discontinue From the Study Due to an Adverse Event
timeFrame: Up to approximately 2 weeks
measure: Total Amount of MK-1084 Excreted Unchanged in Urine (Ae)
timeFrame: At designated timepoints (up to approximately 1 day postdose)
measure: Total Amount of MK-1084 Excreted Unchanged in Urine From 0 to 24 Hours (Ae0-24)
timeFrame: At designated timepoints (up to 24 hours postdose)
measure: Fraction of MK-1084 Excreted Unchanged in Urine (fe)
timeFrame: At designated timepoints (up to approximately 1 day postdose)
measure: Renal Clearance (CLr) of MK-1084
timeFrame: At designated timepoints (up to approximately 1 day postdose)
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center ( Site 0002)
state: Florida
city: Chicago
country: United States
facility: Research by Design ( Site 0001)
state: Illinois
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: