A Study of MK-1084 With Midazolam and Digoxin in Healthy Participants (MK-1084-009)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Digoxin; Drug: MK-1084; Drug: Midazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT06575933

CA43815 (Other Identifier)

MK-1084-009 (Other Identifier)

1084-009

Details and patient eligibility

About

The goal of the study is to see what happens to levels of midazolam and digoxin in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to midazolam and digoxin in the body when it is given with and without another medicine called MK-1084. Researchers are testing if digoxin and midazolam levels in the body are different when digoxin and midazolam are given with or without MK-1084.

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

• Is medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vitals signs, and electrocardiograms (ECGs)
• Has a body mass index (BMI) ≥18 and ≤32 kg/m^2, inclusive

Exclusion criteria

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

• Has a medical history that may confound the results of the study or poses an additional risk to the participant in the study
• Has a history or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Period 1: Midazolam and Digoxin

Experimental group

Description:

Participants will receive a single oral dose of midazolam and a single oral dose of digoxin on Day 1.

Treatment:

Drug: Midazolam

Drug: Digoxin

Period 2: MK-1084, Midazolam, and Digoxin

Experimental group

Description:

A washout period of at least 10 days will occur following midazolam and digoxin dosing in Period 1 and the first MK-1084 dosing in Period 2. Participants will receive MK-1084 once daily on Days 1 through Day 15 with a single oral dose of midazolam on Days 1, 6, and 14 and a single oral dose of digoxin on Days 1 and 11.

Treatment:

Drug: Midazolam

Drug: MK-1084

Drug: Digoxin