NCT05769595

Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012)

A Single-dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-2060 in Japanese Older Participants With End-stage Renal Disease on Dialysis.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-2060 after a single dose intravenous (IV) administration in Japanese older participants with end stage renal disease (ESRD) on dialysis. There is no primary hypothesis for this study.

Conditions

• End-Stage Renal Disease (ESRD)
• End-Stage Kidney Disease (ESKD)
• Kidney Failure, Chronic

Interventions

Type	Name	Description
BIOLOGICAL	MK-2060	Lyophilized powder diluted in normal saline for IV infusion
DRUG	Placebo	IV infusion

Timeline

• Start date: 2023-06-14
• Primary completion: 2024-02-15
• Completion: 2024-02-15
• First posted: 2023-03-15
• Last updated: 2025-03-14
• Results posted: 2025-03-14

Locations

12 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study