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

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

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.
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.
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
Select...
I am generally healthy with no significant medical issues.

Timeline

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
Digoxin
2017
Completed Phase 4
~670
MK-1084
2023
Completed Phase 1
~60

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,985 Previous Clinical Trials
5,178,673 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,868 Previous Clinical Trials
8,082,602 Total Patients Enrolled
~0 spots leftby Oct 2024
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