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

Completed

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 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)