← Back to Search

Other

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose and at designated timepoints up to 24 hours postdose

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

Do I qualify?Apply below to find out