MK-1084 for Kidney Failure

Recruiting at 1 trial location

Overseen By Toll Free Number

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

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the purpose of this trial?

The goal 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 people with moderate or severe renal impairment (RI) (meaning the kidneys do not work properly) as compared to people who are in good health. Researchers also want to learn about the safety of MK-1084 when it is given to people with RI and if people with RI can tolerate it.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for adults with stable kidney function who haven't been on dialysis in the past year. It includes those with moderate or severe renal impairment and healthy individuals, provided they have a BMI between 18.0 and 40.0 kg/m2 and are generally healthy apart from their kidney issues.

Inclusion Criteria

All participants must have a BMI ≥18.0 and ≤40.0 kg/m^2

My kidney function is stable, and I haven't been on dialysis in the last year.

I am healthy with normal kidney function.

Exclusion Criteria

I haven't had cancer before, don't have HIV, hepatitis B or C, and haven't had major surgery or lost a lot of blood in the last 56 days.

I have kidney issues but no history of kidney artery narrowing, transplant, or removal.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of MK-1084 under fasting conditions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and pharmacokinetics of MK-1084

2 weeks

Treatment Details

Interventions

• MK-1084

Trial Overview The study is examining MK-1084 to see how it's processed by people with different levels of kidney health. It compares how long MK-1084 stays in the bodies of those with renal impairment versus healthy participants, while also assessing its safety and tolerability.

Participant Groups

Group I: Panel C: Healthy Experimental Treatment 1 Intervention

Healthy participants will be administered a single oral dose of MK-1084 on Day 1 under fasting conditions.

Group II: Panel B: Moderate RI Experimental Treatment 1 Intervention

Participants with moderate RI will be administered a single oral dose of MK-1084 on Day 1 under fasting conditions.

Group III: Panel A: Severe RI Experimental Treatment 1 Intervention

Participants with severe RI will be administered a single oral dose of MK-1084 on Day 1 under fasting conditions.

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