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

October 29, 2024 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Alliance for Multispecialty Research, LLC (Site 0001)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MK-6552 + Modafinil
In Period 1, participants receive MK-6552 orally. In Period 2, participants receive MK-6552 orally plus low dose modafinil orally. In Period 3, participants receive MK-6552 orally plus high dose modafinil orally.
Drug: MK-6552
Oral administration
Drug: Modafinil
Oral administration
Other Names:
  • Provigil®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 1 month
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.
Up to approximately 19 days
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.
At designated timepoints (up to approximately 36 hours postdose)
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.
At designated timepoints (up to approximately 24 hours postdose)
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.
At designated timepoints (up to approximately 36 hours postdose)
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.
At designated timepoints (up to approximately 36 hours postdose)
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.
At designated timepoints (up to approximately 6 hours postdose)
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
At designated timepoints (up to approximately 8 hours postdose)
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.
At designated timepoints (up to approximately 36 hours postdose)
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.
At designated timepoints (up to approximately 36 hours postdose)
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.
At designated timepoints (up to approximately 36 hours postdose)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At designated timepoints (up to approximately 36 hours postdose)
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.
At designated timepoints (up to approximately 24 hours postdose)
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.
At designated timepoints (up to approximately 36 hours postdose)
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.
At designated timepoints (up to approximately 36 hours postdose)
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.
At designated timepoints (up to approximately 6 hours postdose)
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.
At designated timepoints (up to approximately 8 hours postdose)
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.
At designated timepoints (up to approximately 36 hours postdose)
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.
At designated timepoints (up to approximately 36 hours postdose)
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.
At designated timepoints (up to approximately 36 hours postdose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2023

Primary Completion (Actual)

November 20, 2023

Study Completion (Actual)

November 20, 2023

Study Registration Dates

First Submitted

October 29, 2024

First Submitted That Met QC Criteria

October 29, 2024

First Posted (Actual)

October 30, 2024

Study Record Updates

Last Update Posted (Actual)

October 30, 2024

Last Update Submitted That Met QC Criteria

October 29, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6552-005
  • MK-6552-005 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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