MK-1084 for Healthy Subjects

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Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Cancer, HIV, Hepatitis, others

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

Compensation: Varies

Number of Visits: 2

52 Participants Needed

Trial Summary

What is the purpose of this trial?

This study has 2 parts. Researchers want to learn what happens to MK-1084 in a healthy person's body over time in both parts. The goals of the study are: * In Part 1, to compare what happens to MK-1084 in a person's blood when it is taken as 2 different types of oral tablets * In Part 2, to learn what happens to MK-1084 in a person's blood when it is taken on an empty stomach or after a meal

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for healthy adults with a body mass index (BMI) between 18.0 and 32.0 kg/m^2 who are interested in helping researchers understand how a new medication, MK-1084, behaves in the body.

Inclusion Criteria

My BMI is between 18.0 and 32.0.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Part 1 Treatment

Participants receive low dose MK-1084 as either a film-coated tablet or oral-compressed tablet under fasted conditions

1 day

1 visit (in-person)

Part 2 Treatment

Participants receive higher dose MK-1084 as a film-coated tablet under either fed or fasted conditions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 7 weeks

Treatment Details

Interventions

• MK-1084

Trial Overview The study tests two different oral tablet forms of MK-1084 to see how they affect blood levels over time. It also examines the impact of taking MK-1084 with or without food on its absorption and presence in the bloodstream.

Participant Groups

Group I: Part 2 MK-1084 Treatment D Experimental Treatment 1 Intervention

Participants will be administered higher dose MK-1084 as a FCT on Day 1 under fed conditions (after a high-fat meal)

Group II: Part 2 MK-1084 Treatment C Experimental Treatment 1 Intervention

Participants will be administered higher dose MK-1084 as a FCT on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast)

Group III: Part 1 MK-1084 Treatment B Experimental Treatment 1 Intervention

Participants will be administered low dose MK-1084 as a film-coated tablet (FCT) on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast)

Group IV: Part 1 MK-1084 Treatment A Experimental Treatment 1 Intervention

Participants will be administered low dose MK-1084 as an oral-compressed tablet (OCT) on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast)

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