A Study of MK-1084 in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07219550
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose 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 participants with hepatic (liver) impairment and healthy participants. Researchers also want to learn about the safety of MK-1084 when it is given to people with hepatic impairment and if people with hepatic impairment can tolerate it.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-20
• Study First Submitted QC: 2025-10-20
• Last Update Submitted: 2025-10-20
• Study First Posted: 2025-10-22
• Last Update Posted: 2025-10-22
• Study Start: 2025-11-03
• Primary Completion: 2026-04-17
• Study Completion: 2026-04-17

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MK-1084	MK-1084	All participants will receive a single oral dose of MK-1084 on Day 1.

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration Versus Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of MK-1084	At designated timepoints up to approximately 7 days post-dose	Blood samples will be collected to determine the AUC0-last of MK-1084 in plasma.
Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) of MK-1084	At designated timepoints up to approximately 7 days post-dose	Blood samples will be collected to determine the AUC0-inf of MK-1084 in plasma.
Area Under the Concentration Versus Time Curve from 0 to 24 hours post-dose (AUC0-24) of MK-1084	Up to approximately 24 hours post-dose	Blood samples will be collected to determine the AUC0-24 of MK-1084 in plasma.
Maximum Observed Drug Concentration (Cmax) of MK-1084	At designated timepoints up to approximately 7 days post-dose	Blood samples will be collected to determine the Cmax of MK-1084 in plasma.
Time to Maximum Observed Drug Concentration (Tmax) of MK-1084	At designated timepoints up to approximately 7 days post-dose	Blood samples will be collected to determine the Tmax of MK-1084 in plasma.
Apparent Terminal Half-life (t1/2) of MK-1084	At designated timepoints up to approximately 7 days post-dose	Blood samples will be collected to determine the t1/2 of MK-1084 in plasma.
Apparent Clearance (CL/F) of MK-1084	At designated timepoints up to approximately 7 days post-dose	Blood samples will be collected to determine the CL/F of MK-1084 in plasma.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-1084	At designated timepoints up to approximately 7 days post-dose	Blood samples will be collected to determine the Vz/F of MK-1084 in plasma.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experience an Adverse Event (AE)	Up to approximately 14 days	An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants experiencing AEs will be reported.
Number of Participants Who Discontinue Study Due to an AE	Up to approximately 14 days	An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants discontinuing the study due to AEs will be reported.