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

Phase 1

Recruiting

• Conditions: Healthy; Renal Impairment
• Interventions: Drug: MK-1084

• Registration Number: NCT06814119
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-03
• Study First Posted: 2025-02-07
• Status Verified: 2025-04
• Study Start: 2025-04-07
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-11-27
• Study Completion: 2025-12-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Panel B: Moderate RI	MK-1084	Participants with moderate RI will be administered a single oral dose of MK-1084 on Day 1 under fasting conditions.
Panel A: Severe RI	MK-1084	Participants with severe RI will be administered a single oral dose of MK-1084 on Day 1 under fasting conditions.
Panel C: Healthy	MK-1084	Healthy participants will be administered a single oral dose of MK-1084 on Day 1 under fasting conditions.

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-1084	At designated timepoints (up to approximately 2 days postdose)	Blood samples will be collected to determine the AUC0-inf of MK-1084.
Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of MK-1084	At designated timepoints (up to approximately 2 days postdose)	Blood samples will be collected to determine the AUC0-last of MK-1084.
Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24) of MK-1084	At designated timepoints (up to 24 hours postdose)	Blood samples will be collected to determine the AUC0-24 of MK-1084.
Plasma Concentration of MK-1084 at 24 Hours Postdose (C24)	At designated timepoints (up to 24 hours postdose)	Blood samples will be collected to determine the C24 of MK-1084.
Maximum Plasma Concentration (Cmax) of MK-1084	At designated timepoints (up to approximately 2 days postdose)	Blood samples will be collected to determine the Cmax of MK-1084.
Time to Maximum Plasma Concentration (Tmax) of MK-1084	At designated timepoints (up to approximately 2 days postdose)	Blood samples will be collected to determine the Tmax of MK-1084.
Apparent Terminal Half-life (t1/2) of MK-1084	At designated timepoints (up to approximately 2 days postdose)	Blood samples will be collected to determine the t1/2 of MK-1084.
Apparent Clearance (CL/F) of MK-1084	At designated timepoints (up to approximately 2 days postdose)	Blood samples will be collected to determine the CL/F of MK-1084.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-1084	At designated timepoints (up to approximately 2 days postdose)	Blood samples will be collected to determine the Vz/F of MK-1084.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experience an Adverse Event	Up to approximately 2 weeks	An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. The number of participants who experience an adverse event will be reported.
Number of Participants Who Discontinue From the Study Due to an Adverse Event	Up to approximately 2 weeks	An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. The number of participants who discontinue from the study due to an adverse event will be reported.
Total Amount of MK-1084 Excreted Unchanged in Urine (Ae)	At designated timepoints (up to approximately 1 day postdose)	Urine samples will be collected to determine the Ae of MK-1084.
Total Amount of MK-1084 Excreted Unchanged in Urine From 0 to 24 Hours (Ae0-24)	At designated timepoints (up to 24 hours postdose)	Urine samples will be collected to determine the Ae0-24 of MK-1084.
Fraction of MK-1084 Excreted Unchanged in Urine (fe)	At designated timepoints (up to approximately 1 day postdose)	Urine samples will be collected to determine the fe of MK-1084.
Renal Clearance (CLr) of MK-1084	At designated timepoints (up to approximately 1 day postdose)	Urine samples will be collected to determine the CLr of MK-1084.

Trial Locations

Locations (1)

Orlando Clinical Research Center ( Site 0002); 🇺🇸 Orlando, Florida, United States