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

NCT06619665 | Completed Phase 1 FDA Drug

• 2 other identifiers: 6552-003MK-6552-003
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy; Narcolepsy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Area under the concentration=time curve (AUC) for plasma MK-6552

  At designated timepoints up to 24 hours postdose

• Concentration of plasma MK-6522 at Tmax following morning (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

  Tmax following PM dose (at designated timepoints up to 24 hours postdose)

• Concentration of plasma MK-6552 8 hours (C8h) after first dose

  8 hours

• Concentration of plasma MK-6552 24 hours (C24h) after first dose

  24 hours

Study Arms (6)

MK-6552-Placebo-Modafinil

EXPERIMENTAL

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; Drug: MK-6552 placebo; Drug: Modafinil; Drug: Modafinil placebo

MK-6552-Modafinil-Placebo

EXPERIMENTAL

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; Drug: MK-6552 placebo; Drug: Modafinil; Drug: Modafinil placebo

Placebo-Modafinil-MK-6552

EXPERIMENTAL

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; Drug: MK-6552 placebo; Drug: Modafinil; Drug: Modafinil placebo

Placebo-MK-6552-Modafinil

EXPERIMENTAL

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; Drug: MK-6552 placebo; Drug: Modafinil; Drug: Modafinil placebo

Modafinil-MK-6552-Plaebo

EXPERIMENTAL

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; Drug: MK-6552 placebo; Drug: Modafinil; Drug: Modafinil placebo

Modafinil-Plaebo-MK-6552

EXPERIMENTAL

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; Drug: MK-6552 placebo; Drug: Modafinil; Drug: Modafinil placebo

Interventions

MK-6552 DRUG

MK-6552 gelatin coated capsules taken orally two times 8 hours apart

MK-6552-Modafinil-Placebo; MK-6552-Placebo-Modafinil; Modafinil-MK-6552-Plaebo; Modafinil-Plaebo-MK-6552; Placebo-MK-6552-Modafinil; Placebo-Modafinil-MK-6552

MK-6552 placebo DRUG

MK-6552 placebo gelatin coated capsules taken orally two times 8 hours apart

MK-6552-Modafinil-Placebo; MK-6552-Placebo-Modafinil; Modafinil-MK-6552-Plaebo; Modafinil-Plaebo-MK-6552; Placebo-MK-6552-Modafinil; Placebo-Modafinil-MK-6552

Modafinil DRUG

Modafinil tablet taken once orally

MK-6552-Modafinil-Placebo; MK-6552-Placebo-Modafinil; Modafinil-MK-6552-Plaebo; Modafinil-Plaebo-MK-6552; Placebo-MK-6552-Modafinil; Placebo-Modafinil-MK-6552

Modafinil placebo DRUG

Modafinil placebo tablet taken once orally

MK-6552-Modafinil-Placebo; MK-6552-Placebo-Modafinil; Modafinil-MK-6552-Plaebo; Modafinil-Plaebo-MK-6552; Placebo-MK-6552-Modafinil; Placebo-Modafinil-MK-6552

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Criteria include but are not limited to the following:
• History of or current hypertension,
• Has a history of sleep disorders:

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (2)

NeuroTrials Research Inc (Site 0001)

Atlanta, Georgia, 30328, United States

Location

Clinilabs (Site 0003)

Eatontown, New Jersey, 07724, 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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: March 19, 2024
• Primary Completion: July 16, 2024
• Study Completion: July 16, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

US (2)