A Study of MK-6552 in Sleep Deprived Healthy Participants (MK-6552-003)

A Randomized, Double-blind, 3-Period Crossover Study to Assess the Effects of MK-6552 on Sleep Latency in Sleep Deprived Healthy Participants With Modafinil as a Positive Control

This study examined the safety of the drug MK-6552 and if people tolerated it. It also studied whether MK-6552 works better than placebo for staying awake in sleep deprived healthy participants.

Study Overview

• Status: Completed
• Conditions: Healthy; Narcolepsy
• Intervention / Treatment: Drug: MK-6552; Drug: MK-6552 placebo; Drug: Modafinil; Drug: Modafinil placebo

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • NeuroTrials Research Inc (Site 0001)
  • New Jersey
    • Eatontown, New Jersey, United States, 07724
      • Clinilabs (Site 0003)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Criteria include but are not limited to the following:

• Is in good health
• Body Mass Index (BMI) between 18 and 32 kg/m^2, inclusive.

Exclusion Criteria:

Criteria include but are not limited to the following:

• History of or current hypertension,
• Has a history of sleep disorders:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MK-6552-Placebo-Modafinil; Participants were treated in period 1 with MK-6552; in period 2 with placebos to Modafinil and MK-6552; and in period 3 with Modafinil; with a 7-day washout between each period.	Drug: MK-6552; MK-6552 gelatin coated capsules taken orally two times 8 hours apart; Drug: MK-6552 placebo; MK-6552 placebo gelatin coated capsules taken orally two times 8 hours apart; Drug: Modafinil; Modafinil tablet taken once orally; Drug: Modafinil placebo; Modafinil placebo tablet taken once orally
Experimental: MK-6552-Modafinil-Placebo; Participants were treated in period 1 with MK-6552; in period 2 with Modafinil; and in period 3 with placebos to Modafinil and MK-6552; with a 7-day washout between each period.	Drug: MK-6552; MK-6552 gelatin coated capsules taken orally two times 8 hours apart; Drug: MK-6552 placebo; MK-6552 placebo gelatin coated capsules taken orally two times 8 hours apart; Drug: Modafinil; Modafinil tablet taken once orally; Drug: Modafinil placebo; Modafinil placebo tablet taken once orally
Experimental: Placebo-Modafinil-MK-6552; Participants were treated in period 1 with placebos to Modafinil and MK-6552; in period 2 with Modafinil; and in period 3 with MK-6552; with a 7-day washout between each period.	Drug: MK-6552; MK-6552 gelatin coated capsules taken orally two times 8 hours apart; Drug: MK-6552 placebo; MK-6552 placebo gelatin coated capsules taken orally two times 8 hours apart; Drug: Modafinil; Modafinil tablet taken once orally; Drug: Modafinil placebo; Modafinil placebo tablet taken once orally
Experimental: Placebo-MK-6552-Modafinil; Participants were treated in period 1 with placebos to Modafinil and MK-6552; in period 2 with MK-6552; and in period 3 with Modafinil; with a 7-day washout between each period.	Drug: MK-6552; MK-6552 gelatin coated capsules taken orally two times 8 hours apart; Drug: MK-6552 placebo; MK-6552 placebo gelatin coated capsules taken orally two times 8 hours apart; Drug: Modafinil; Modafinil tablet taken once orally; Drug: Modafinil placebo; Modafinil placebo tablet taken once orally
Experimental: Modafinil-MK-6552-Plaebo; Participants were treated in period 1 with Modafinil; in period 2 withMK-6552; and in period 3 with placebos to Modafinil and MK-6552; with a 7-day washout between each period.	Drug: MK-6552; MK-6552 gelatin coated capsules taken orally two times 8 hours apart; Drug: MK-6552 placebo; MK-6552 placebo gelatin coated capsules taken orally two times 8 hours apart; Drug: Modafinil; Modafinil tablet taken once orally; Drug: Modafinil placebo; Modafinil placebo tablet taken once orally
Experimental: Modafinil-Plaebo-MK-6552; Participants were treated in period 1 with Modafinil; in period 2 with placebos to Modafinil and MK-6552; and in period 3 with MK-6552; with a 7-day washout between each period.	Drug: MK-6552; MK-6552 gelatin coated capsules taken orally two times 8 hours apart; Drug: MK-6552 placebo; MK-6552 placebo gelatin coated capsules taken orally two times 8 hours apart; Drug: Modafinil; Modafinil tablet taken once orally; Drug: Modafinil placebo; Modafinil placebo tablet taken once orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants with an Adverse Event (AE)	Percentage of participants with at least one AE	Up to Day 30
Participants who discontinued from study due to an AE	Percentage of participants who discontinued from study due to an AE	Day 1
Maintenance of Wakefulness Test (MWT) for MK-6552	Sleep latency of MWT for MK-6552 compared with placebo	Postdose time to maximum plasma concentration (Tmax) (at designated timepoints up to 24 hours postdose)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the concentration=time curve (AUC) for plasma MK-6552	AUC for plasma MK-6552 from 0-24 hours postdose	At designated timepoints up to 24 hours postdose
Concentration of plasma MK-6522 at Tmax following morning (AM) dose	Plasma concentration of MK-6552 at Tmax following AM dose	Tmax following AM dose (at designated timepoints up to 24 hours postdose)
Concentration of plasma MK-6522 at Tmax following afternoon (PM) dose	Plasma concentration of MK-6552 at Tmax following PM dose	Tmax following PM dose (at designated timepoints up to 24 hours postdose)
Concentration of plasma MK-6552 8 hours (C8h) after first dose	C8h of plasma MK-6552 after first dose	8 hours
Concentration of plasma MK-6552 24 hours (C24h) after first dose	C24h of plasma MK-6552 after first dose	24 hours
MWT for Modafinil	Sleep latency of MWT for Modafinil compared with placebo	2 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): March 19, 2024
• Primary Completion (Actual): July 16, 2024
• Study Completion (Actual): July 16, 2024

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disorders of Excessive Somnolence; Narcolepsy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Central Nervous System Stimulants; Wakefulness-Promoting Agents; Modafinil
• Other Study ID Numbers: 6552-003; MK-6552-003 (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