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Completed

NCT Number: NCT06586606

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

QPS-MRA, LLC ( Site 0001)

South Miami, Florida, 33143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria include but are not limited to the following:

  • Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
  • Has a history of cancer

Treatment and study plan

MK-1708

Drug

Oral administration

Itraconazole

Drug

Oral administration

Primary outcomes

  1. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-1708

    Time frame: Predose and at designated timepoints up to approximately 2 weeks postdose

    Blood samples will be collected to determine the AUC0-inf of MK-1708.

  2. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 11 weeks

    An 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.

  3. Number of Participants Who Discontinue Study Due to an AE

    Time frame: Up to approximately 11 weeks

    An 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 outcomes

  1. Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-Last) of MK-1708

    Time frame: Predose and at designated timepoints up to approximately 2 weeks postdose

    Blood samples will be collected to determine the AUC0-last of MK-1708.

  2. Maximum Plasma Concentration (Cmax) of MK-1708

    Time frame: Predose and at designated timepoints up to approximately 2 weeks postdose

    Blood samples will be collected to determine the Cmax of MK-1708.

  3. Time to Maximum Plasma Concentration (Tmax) of MK-1708

    Time frame: Predose and at designated timepoints up to approximately 2 weeks postdose

    Blood samples will be collected to determine the Tmax of MK-1708.

  4. Plasma Concentration at 24 Hours (C24) of MK-1708

    Time frame: Predose and at designated timepoints up to 24 hours postdose

    Blood samples will be collected to determine the C24 of MK-1708.

  5. Apparent Clearance (CL/F) of MK-1708

    Time frame: Predose and at designated timepoints up to approximately 2 weeks postdose

    Blood samples will be collected to determine the CL/F of MK-1708.

  6. Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-1708

    Time frame: Predose and at designated timepoints up to approximately 2 weeks postdose

    Blood samples will be collected to determine the Vz/F of MK-1708.

  7. Apparent Terminal Half-life (t1/2) of MK-1708

    Time frame: Predose and at designated timepoints up to approximately 2 weeks postdose

    Blood samples will be collected to determine the t1/2 of MK-1708.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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