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A Study to Evaluate the Effect of Food, Formulation, and a Proton Pump Inhibitor (PPI) on MK-1084 in Healthy Adult Participants (MK-1084-003)

NCT ID: NCT06619314

Last Updated: 2024-10-01

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-20

Study Completion Date

2023-11-25

Brief Summary

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The purpose of this study is to evaluate the effect of food, formulation, and a PPI on the levels of MK-1084 in a person's body over time.

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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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MK-1084 Treatment A

Participants will receive MK-1084 on Day 1 on an empty stomach

Group Type EXPERIMENTAL

MK-1084

Intervention Type DRUG

Oral Tablet

MK-1084 Treatment B

Participants will receive MK-1084 on Day 1 after a high-fat/high-calorie breakfast

Group Type EXPERIMENTAL

MK-1084

Intervention Type DRUG

Oral Tablet

MK-1084 Treatment C

Participants will receive MK-1084 Formulation 1 on Day 1

Group Type EXPERIMENTAL

MK-1084

Intervention Type DRUG

Oral Tablet

MK-1084 Treatment D

Participants will receive MK-1084 Formulation 2 on Day 1

Group Type EXPERIMENTAL

MK-1084

Intervention Type DRUG

Oral Tablet

MK-1084 Treatment E

Participants will receive MK-1084 without a PPI on Day 1

Group Type EXPERIMENTAL

MK-1084

Intervention Type DRUG

Oral Tablet

MK-1084 Treatment F

Participants will receive MK-1084 with a PPI on Day 5

Group Type EXPERIMENTAL

MK-1084

Intervention Type DRUG

Oral Tablet

PPI

Intervention Type DRUG

Oral Capsule

Interventions

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MK-1084

Oral Tablet

Intervention Type DRUG

PPI

Oral Capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing.
* Medically healthy with no clinically significant medical history.

Exclusion Criteria

* Has a history of cancer.
* Has had major surgery and/or donated or lost significant volume of blood.
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 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)

Lincoln, Nebraska, 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-1084-003

Identifier Type: OTHER

Identifier Source: secondary_id

1084-003

Identifier Type: -

Identifier Source: org_study_id

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