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A Study to Evaluate the Effects of Itraconazole on MK-1708 in Healthy Participants (MK-1708-003)

A Two-Period Study to Evaluate the Effects of Multiple Oral Doses of Itraconazole on the Single Dose PK of MK-1708 in Healthy Participants

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06586606
Enrollment
12
Registered
2024-09-19
Start date
2024-10-03
Completion date
2024-12-10
Last updated
2024-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Brief summary

The goal of the study is to see what happens to levels of MK-1708 a person's body over time. Researchers will compare what happens to MK-1708 in the body when it is given with or without a medicine called itraconazole.

Interventions

Oral administration

DRUGItraconazole

Oral administration

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

The key inclusion criteria include but are not limited to the following: * Is in good health before randomization * Has a body mass index (BMI) ≥18.5 and ≤32 kg/m\^2, inclusive

Exclusion criteria

The key

Design outcomes

Primary

MeasureTime frameDescription
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-1708Predose and at designated timepoints up to approximately 2 weeks postdoseBlood samples will be collected to determine the AUC0-inf of MK-1708.
Number of Participants Who Experience an Adverse Event (AE)Up to approximately 11 weeksAn AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Due to an AEUp to approximately 11 weeksAn AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study due to an AE will be reported.

Secondary

MeasureTime frameDescription
Plasma Concentration at 24 Hours (C24) of MK-1708Predose and at designated timepoints up to 24 hours postdoseBlood samples will be collected to determine the C24 of MK-1708.
Apparent Clearance (CL/F) of MK-1708Predose and at designated timepoints up to approximately 2 weeks postdoseBlood samples will be collected to determine the CL/F of MK-1708.
Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-Last) of MK-1708Predose and at designated timepoints up to approximately 2 weeks postdoseBlood samples will be collected to determine the AUC0-last of MK-1708.
Apparent Terminal Half-life (t1/2) of MK-1708Predose and at designated timepoints up to approximately 2 weeks postdoseBlood samples will be collected to determine the t1/2 of MK-1708.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-1708Predose and at designated timepoints up to approximately 2 weeks postdoseBlood samples will be collected to determine the Vz/F of MK-1708.
Maximum Plasma Concentration (Cmax) of MK-1708Predose and at designated timepoints up to approximately 2 weeks postdoseBlood samples will be collected to determine the Cmax of MK-1708.
Time to Maximum Plasma Concentration (Tmax) of MK-1708Predose and at designated timepoints up to approximately 2 weeks postdoseBlood samples will be collected to determine the Tmax of MK-1708.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026