NCT06814132

A Study to Evaluate the Effect of MK-5684 in Male Participants With Severe Renal Impairment (RI) and With End-stage Renal Disease (ESRD) (MK-5684-010)

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-5684 in Male Participants With Severe Renal Impairment and With End-stage Renal Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The goal of the study is to learn what happens to levels of MK-5684 in people with severe renal impairment and end-stage renal disease versus a healthy person's body over time. Researchers will compare what happens to MK-5684 after hemodialysis in people with severe renal impairment and end-stage renal disease versus healthy people.

Conditions

• Kidney Failure, Chronic
• End-Stage Kidney Disease
• Renal Failure, Chronic
• Renal Failure, End-Stage
• Healthy Participants

Interventions

Type	Name	Description
DRUG	MK-5684	Oral tablet
DRUG	Prednisone	Oral tablet
DRUG	Fludrocortisone acetate	Oral tablet

Timeline

• Start date: 2025-04-07
• Primary completion: 2025-10-04
• Completion: 2025-10-14
• First posted: 2025-02-07
• Last updated: 2025-10-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study