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MK-1084 with Midazolam and Digoxin for Non-Small Cell Lung Cancer

Tempe, AZ

Phase 1

Waitlist Available

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vitals signs, and electrocardiograms (ECGs)

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 1 month

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see how the levels of midazolam and digoxin change in the body over time. Researchers will be comparing the effects of giving midazolam and digoxin

See full description

Who is the study for?

This trial is for healthy individuals with a BMI between 18 and 32. Participants should have no significant medical history, abnormal lab results, vital signs, or ECGs that could affect the study's outcome.Check my eligibility

What is being tested?

The study tests how MK-1084 affects the body's handling of midazolam and digoxin—two established medications. It compares levels of these drugs in the body when taken alone versus alongside MK-1084 to see if there are any differences.See study design

What are the potential side effects?

Since this is a pharmacokinetic study primarily looking at drug levels rather than therapeutic effects, specific side effects aren't detailed here. However, common side effects of midazolam include drowsiness and light-headedness; digoxin can cause nausea and heart rhythm problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am generally healthy with no significant medical issues.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AUC0-24hr of Digoxin

AUC0-Inf of Digoxin

AUC0-Last of Digoxin

+13 more

Secondary study objectives

AUC0-24 Accumulation Ratio of MK-1084

AUC0-24hr of MK-1084

AUC0-Last of MK-1084

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Period 2: MK-1084, Midazolam, and DigoxinExperimental Treatment3 Interventions

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 II: Period 1: Midazolam and DigoxinExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Midazolam

2018

Completed Phase 4

~1910

MK-1084

2024