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)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PPI; Drug: MK-1084

Study type: Interventional

Funder types: Industry

Identifiers

NCT06619314

MK-1084-003 (Other Identifier)

1084-003

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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56 participants in 6 patient groups

MK-1084 Treatment A

Experimental group

Description:

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

Treatment:

Drug: MK-1084

MK-1084 Treatment B

Experimental group

Description:

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

Treatment:

Drug: MK-1084

MK-1084 Treatment C

Experimental group

Description:

Participants will receive MK-1084 Formulation 1 on Day 1

Treatment:

Drug: MK-1084

MK-1084 Treatment D

Experimental group

Description:

Participants will receive MK-1084 Formulation 2 on Day 1

Treatment:

Drug: MK-1084

MK-1084 Treatment E

Experimental group

Description:

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

Treatment:

Drug: MK-1084

MK-1084 Treatment F

Experimental group

Description:

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

Treatment:

Drug: PPI

Drug: MK-1084