MK-8527 for Kidney Failure

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Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Cancer, HIV, Hepatitis B/C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

18 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to evaluate the effect of moderate and severe renal impairment (RI) on the pharmacokinetics (PK), safety, and tolerability of MK-8527. There will be no hypothesis testing in the study.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for adults with moderate to severe kidney failure who are otherwise healthy and have stable kidney function. It includes those with normal renal function matched by age to participants with impaired kidneys.

Inclusion Criteria

Aside from kidney issues, I am healthy enough for the study.

My age matches the average age of participants with moderate to severe renal impairment.

My kidney function is stable despite having moderate to severe kidney issues.

Exclusion Criteria

I have not had major surgery or lost a lot of blood in the last 56 days.

I donated plasma within the last week.

I have kidney issues due to a failed transplant or had a kidney removed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of MK-8527 on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Multiple visits for PK sampling

Treatment Details

Interventions

• MK-8527

Trial Overview The study is testing MK-8527 in individuals with different levels of kidney health. It aims to understand how the drug behaves in the body (its pharmacokinetics), its safety, and how well it's tolerated without making any predictions or comparisons.

Participant Groups

Group I: Severe Renal Impairment Experimental Treatment 1 Intervention

Participants with severe renal impairment receive a single dose of MK-8527 on Day 1.

Group II: Moderate Renal Impairment Experimental Treatment 1 Intervention

Participants with moderate renal impairment receive a single dose of MK-8527 on Day 1.

Group III: Healthy Experimental Treatment 1 Intervention

Healthy participants receive a single dose of MK-8527 on Day 1.

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