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Completed

NCT Number: NCT06665230

A Clinical Study of MK-6552 and Modafinil in Healthy Men (MK-6552-005)

The goal of this study is to learn what happens to MK-6552 in a person's body over time. Researchers will compare what happens to levels of MK-6552 in people's blood when it is taken with and without modafinil. Researchers also want to learn about the safety of MK-6552 taken with and without modafinil and if people tolerate it.

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Key information

Conditions

Healthy Disorders of Excessive Somnolence Dyssomnias Mental Disorders Narcolepsy Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Alliance for Multispecialty Research, LLC (Site 0001)

Knoxville, Tennessee, 37920, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

  • Is in good health based on medical history and physical examination
  • Has a body mass index ≥18 and ≤32 kg/m^2, inclusive

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

  • Has a history of clinically significant endocrine, gastrointestinal, 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-6552

Drug

Oral administration

Modafinil

Drug

Oral administration

Other names: Provigil®

Primary outcomes

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

    Time frame: Up to approximately 1 month

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  2. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 19 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  3. High Dose Modafinil Effect: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552

    Time frame: At designated timepoints (up to approximately 36 hours postdose)

    Blood samples will be collected to determine the AUC0-inf of MK-6552 in the presence of high dose modafinil.

  4. High Dose Modafinil Effect: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-6552

    Time frame: At designated timepoints (up to approximately 24 hours postdose)

    Blood samples will be collected to determine the AUC0-24hrs of MK-6552 in the presence of high dose modafinil.

  5. High Dose Modafinil Effect: Time to Maximum Plasma Concentration (Tmax) of MK-6552

    Time frame: At designated timepoints (up to approximately 36 hours postdose)

    Blood samples will be collected to determine the Tmax of MK-6552 in the presence of high dose modafinil.

  6. High Dose Modafinil Effect: Maximum Plasma Concentration (Cmax) of MK-6552

    Time frame: At designated timepoints (up to approximately 36 hours postdose)

    Blood samples will be collected to determine the Cmax of MK-6552 in the presence of high dose modafinil.

  7. High Dose Modafinil Effect: Plasma Concentration of MK-6552 at 6 Hours Postdose (C6hrs)

    Time frame: At designated timepoints (up to approximately 6 hours postdose)

    Blood samples will be collected to determine the C6hrs of MK-6552 in the presence of high dose modafinil.

  8. High Dose Modafinil Effect: Plasma Concentration of MK-6552 at 8 Hours Postdose (C8hrs)

    Time frame: At designated timepoints (up to approximately 8 hours postdose)

    Blood samples will be collected to determine the C8hrs of MK-6552 in the presence of high dose modafinil

  9. High Dose Modafinil Effect: Apparent Clearance (CL/F) of MK-6552

    Time frame: At designated timepoints (up to approximately 36 hours postdose)

    Blood samples will be collected to determine the CL/F of MK-6552 in the presence of high dose modafinil.

  10. High Dose Modafinil Effect: Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-6552

    Time frame: At designated timepoints (up to approximately 36 hours postdose)

    Blood samples will be collected to determine the Vz/F of MK-6552 in the presence of high dose modafinil.

  11. High Dose Modafinil Effect: Apparent Terminal Half-life (t1/2) of MK-6552

    Time frame: At designated timepoints (up to approximately 36 hours postdose)

    Blood samples will be collected to determine the t1/2 of MK-6552 in the presence of high dose modafinil.

Secondary outcomes

  1. Low Dose Modafinil Effect: AUC0-inf of MK-6552

    Time frame: At designated timepoints (up to approximately 36 hours postdose)

    Blood samples will be collected to determine the AUC0-inf of MK-6552 in the presence of low dose modafinil.

  2. Low Dose Modafinil Effect: AUC0-24hrs of MK-6552

    Time frame: At designated timepoints (up to approximately 24 hours postdose)

    Blood samples will be collected to determine the AUC0-24hrs of MK-6552 in the presence of low dose modafinil.

  3. Low Dose Modafinil Effect: Tmax of MK-6552

    Time frame: At designated timepoints (up to approximately 36 hours postdose)

    Blood samples will be collected to determine the Tmax of MK-6552 in the presence of low dose modafinil.

  4. Low Dose Modafinil Effect: Cmax of MK-6552

    Time frame: At designated timepoints (up to approximately 36 hours postdose)

    Blood samples will be collected to determine the Cmax of MK-6552 in the presence of low dose modafinil.

  5. Low Dose Modafinil Effect: C6hrs of MK-6552

    Time frame: At designated timepoints (up to approximately 6 hours postdose)

    Blood samples will be collected to determine the C6hrs of MK-6552 in the presence of low dose modafinil.

  6. Low Dose Modafinil Effect: C8hrs of MK-6552

    Time frame: At designated timepoints (up to approximately 8 hours postdose)

    Blood samples will be collected to determine the C8hrs of MK-6552 in the presence of low dose modafinil.

  7. Low Dose Modafinil Effect: CL/F of MK-6552

    Time frame: At designated timepoints (up to approximately 36 hours postdose)

    Blood samples will be collected to determine the CL/F of MK-6552 in the presence of low dose modafinil.

  8. Low Dose Modafinil Effect: Vz/F of MK-6552

    Time frame: At designated timepoints (up to approximately 36 hours postdose)

    Blood samples will be collected to determine the Vz/F of MK-6552 in the presence of low dose modafinil.

  9. Low Dose Modafinil Effect: t1/2 of MK-6552

    Time frame: At designated timepoints (up to approximately 36 hours postdose)

    Blood samples will be collected to determine the t1/2 of MK-6552 in the presence of low dose modafinil.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Three-Period Study to Evaluate the Effects of Modafinil on the Single-Dose Pharmacokinetics of MK-6552 in Healthy Male Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 30, 2024
Registry last updated
Oct 30, 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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