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

NCT06665230 | Completed Phase 1 FDA Drug

• 2 other identifiers: 6552-005MK-6552-005
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Narcolepsy

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (9)

• Low Dose Modafinil Effect: AUC0-inf of MK-6552

  At designated timepoints (up to approximately 36 hours postdose)

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

  At designated timepoints (up to approximately 24 hours postdose)

• Low Dose Modafinil Effect: Tmax of MK-6552

  At designated timepoints (up to approximately 36 hours postdose)

• Low Dose Modafinil Effect: Cmax of MK-6552

  At designated timepoints (up to approximately 36 hours postdose)

• Low Dose Modafinil Effect: C6hrs of MK-6552

  At designated timepoints (up to approximately 6 hours postdose)

Study Arms (1)

MK-6552 + Modafinil

EXPERIMENTAL

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; Drug: Modafinil

Interventions

MK-6552 DRUG

Oral administration

MK-6552 + Modafinil

Modafinil DRUG

Oral administration

Also known as: Provigil®

MK-6552 + Modafinil

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Alliance for Multispecialty Research, LLC (Site 0001)

Knoxville, Tennessee, 37920, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Narcolepsy

Interventions

Modafinil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: September 20, 2023
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)