A Study to Evaluate the Effect of Formulation and Food on MK-1084 in Healthy Adult Participants (MK-1084-011)

NCT ID: NCT06942741

Last Updated: 2025-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-13

Study Completion Date

2025-08-04

Brief Summary

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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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Part 1 MK-1084 Treatment A

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)

Group Type EXPERIMENTAL

MK-1084 OCT

Intervention Type DRUG

Oral tablet

Part 1 MK-1084 Treatment B

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 Type EXPERIMENTAL

MK-1084 FCT

Intervention Type DRUG

Oral tablet

Part 2 MK-1084 Treatment C

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 Type EXPERIMENTAL

MK-1084 FCT

Intervention Type DRUG

Oral tablet

Part 2 MK-1084 Treatment D

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

Group Type EXPERIMENTAL

MK-1084 FCT

Intervention Type DRUG

Oral tablet

Interventions

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MK-1084 OCT

Oral tablet

Intervention Type DRUG

MK-1084 FCT

Oral tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Has a body mass index ≥18.0 and ≤32.0 kg/m\^2

Exclusion Criteria

* Has a history or presence of a clinically significant medical or psychiatric condition or disease
* Has a history of cancer (malignancy)
* Has positive results for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Celerion ( Site 0001)

Tempe, Arizona, United States

Site Status

Countries

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United States

Related Links

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https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

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MK-1084-011

Identifier Type: OTHER

Identifier Source: secondary_id

1084-011

Identifier Type: -

Identifier Source: org_study_id

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