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

Merck Sharp & Dohme (MSD)

Status and phase

Enrolling

Phase 1

Conditions

Healthy

Treatments

Drug: MK-1084 FCT

Drug: MK-1084 OCT

Study type

Interventional

Funder types

Industry

Identifiers

NCT06942741

MK-1084-011 (Other Identifier)

1084-011

Details and patient eligibility

About

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

Enrollment

52 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

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

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

52 participants in 4 patient groups

Part 1 MK-1084 Treatment A

Experimental group

Description:

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)

Treatment:

Drug: MK-1084 OCT

Part 1 MK-1084 Treatment B

Experimental group

Description:

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)

Treatment:

Drug: MK-1084 FCT

Part 2 MK-1084 Treatment C

Experimental group

Description:

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)

Treatment:

Drug: MK-1084 FCT

Part 2 MK-1084 Treatment D

Experimental group

Description:

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