MK-8527 for Healthy Subjects

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Endocrine, Cardiovascular, Neurological, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

12 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 how MK-8527 moves through the healthy person's body over time. Researchers will measure for the amount of MK-8527 in breast milk that the baby will receive at many time points.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for healthy lactating women who are at least 6 weeks postpartum, have delivered a healthy baby, and can express breast milk twice daily for over 120 hours after joining. Participants must stop breastfeeding from the time they take MK-8527 until six weeks after to ensure safety.

Inclusion Criteria

I gave birth to a healthy baby more than 6 weeks ago.

I can and will pump breast milk twice daily for 5 days after joining.

I agree to stop breastfeeding and use alternative feeding for my baby for 6 weeks after treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

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

1 day

Pharmacokinetic Monitoring

Breast milk, plasma, and blood samples are collected to measure MK-8527 concentration at various time points

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MK-8527

Trial Overview Researchers are studying how MK-8527 is processed in the body and how much enters breast milk. They'll check levels of this drug in the milk at different times to understand what babies might ingest.

Participant Groups

Group I: MK-8527 Experimental Treatment 1 Intervention

Participants receive single oral 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