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

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-03

Study Completion Date

2024-10-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Period 1: Midazolam and Digoxin

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

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

Oral administration

Digoxin

Intervention Type DRUG

Oral administration

Period 2: MK-1084, Midazolam, and Digoxin

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.

Group Type EXPERIMENTAL

MK-1084

Intervention Type DRUG

Oral administration

Midazolam

Intervention Type DRUG

Oral administration

Digoxin

Intervention Type DRUG

Oral administration

Interventions

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MK-1084

Oral administration

Intervention Type DRUG

Midazolam

Oral administration

Intervention Type DRUG

Digoxin

Oral administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes