MK-5684 for Kidney Disease

Recruiting at 1 trial location

Overseen By Toll Free Number

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Merck Sharp & Dohme LLC

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for males with severe renal impairment or end-stage renal disease who are on stable hemodialysis, as well as healthy individuals. Participants should be non-smokers or moderate smokers and have a BMI between 18.0 and 42.0 kg/m^2. Those with normal kidney function can also join to serve as a comparison group.

Inclusion Criteria

I am willing to participate in this study.

I have smoked 10 or fewer cigarettes daily for the last 3 months.

My kidney function is normal.

Treatment Details

Interventions

• Fludrocortisone acetate (Corticosteroid)
• MK-5684 (Corticosteroid)
• Prednisone (Corticosteroid)

Trial Overview The study examines how the body processes MK-5684 in people with severe kidney issues compared to healthy individuals. It will also look at the effects of MK-5684 after hemodialysis treatments in those with serious kidney conditions.

Participant Groups

Group I: Group 3: Healthy Participants Experimental Treatment 3 Interventions

Participants will receive a single oral dose of MK-5684 under fasting conditions (on an empty stomach after a 10-hour overnight fast) on Day 1 and a single dose of Hormone replacement therapy (HRT) (prednisone and fludrocortisone) administered approximately 4.5 hours after MK-5684 dosing under fed conditions (eating a normal meal).

Group II: Group 2: End-stage renal disease (ESRD) Experimental Treatment 3 Interventions

Participants will receive a single oral dose of MK-5684 under fasting conditions (on an empty stomach after a 10-hour overnight fast) in Period 1 and Period 2. In Period 1, participants will receive a single oral dose of MK-5684 approximately 30 minutes prior to their normally scheduled hemodialysis (HD), followed by HRT under fed conditions (eating a normal meal) 4.5 hours after MK-5684 dosing. In Period 2, participants will receive a single oral dose of MK-5684 immediately followed by completion of their normally scheduled HD, and by HRT under fed conditions (eating a normal meal) 4.5 hours after MK-5684 dosing.

Group III: Group 1: Severe Renal Impairment (RI) Experimental Treatment 3 Interventions

Participants will receive a single oral dose of MK-5684 under fasting conditions (on an empty stomach after a 10-hour overnight fast) on Day 1 and a single dose of Hormone replacement therapy (HRT) (prednisone and fludrocortisone) administered approximately 4.5 hours after MK-5684 dosing under fed conditions (eating a normal meal).

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University