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Itraconazole + MK-1708 for Alzheimer's Disease

Phase 1
Recruiting
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose and at designated timepoints up to 24 hours postdose
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study how the levels of MK-1708 change in the body over time. Researchers will compare the effects of MK-1708 when it is taken alone versus when it is taken

Who is the study for?
This trial is for healthy individuals with a BMI between 18.5 and 32 kg/m2. Participants should be in good health without any significant medical conditions.
What is being tested?
The study aims to understand how the drug MK-1708 behaves in the body over time, especially when taken with or without another medication called itraconazole.
What are the potential side effects?
Potential side effects are not detailed here, but generally, Itraconazole can cause nausea, headache, stomach pain, and dizziness; MK-1708's side effects will be monitored.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose and at designated timepoints up to 24 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose and at designated timepoints up to 24 hours postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-1708
Number of Participants Who Discontinue Study Due to an AE
Number of Participants Who Experience an Adverse Event (AE)
Secondary study objectives
Apparent Clearance (CL/F) of MK-1708
Apparent Terminal Half-life (t1/2) of MK-1708
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-1708
+4 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-1708 and ItraconazoleExperimental Treatment2 Interventions
A washout period of at least 10 days will occur between MK-1708 dosing in Period 1 and the first itraconazole dosing in Period 2. In Period 2, participants will receive itraconazole twice daily on Day 1 and once daily on Days 2 through Day 19. Participants will also receive a single oral dose of MK-1708 on Day 4.
Group II: Period 1: MK-1708Experimental Treatment1 Intervention
Participants will receive a single oral dose of MK-1708 on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itraconazole
2017
Completed Phase 2
~830

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,996 Previous Clinical Trials
5,181,230 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,877 Previous Clinical Trials
8,084,821 Total Patients Enrolled
~6 spots leftby Dec 2024
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