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

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: Healthy; Narcolepsy
• Intervention / Treatment: Drug: MK-6552; Drug: Modafinil

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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)	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	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	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	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	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	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)	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)	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	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	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	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	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	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	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	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	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	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	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	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	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

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

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

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: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Disorders of Excessive Somnolence; Narcolepsy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Stimulants; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Wakefulness-Promoting Agents; Modafinil
• 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