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Completed

NCT Number: NCT06619665

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

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NeuroTrials Research Inc (Site 0001), Atlanta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

Treatment and study plan

MK-6552

Drug

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

MK-6552 placebo

Drug

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

Modafinil

Drug

Modafinil tablet taken once orally

Modafinil Placebo

Drug

Modafinil placebo tablet taken once orally

Primary outcomes

  1. Participants with an Adverse Event (AE)

    Time frame: Up to Day 30

    Percentage of participants with at least one AE

  2. Participants who discontinued from study due to an AE

    Time frame: Day 1

    Percentage of participants who discontinued from study due to an AE

  3. Maintenance of Wakefulness Test (MWT) for MK-6552

    Time frame: Postdose time to maximum plasma concentration (Tmax) (at designated timepoints up to 24 hours postdose)

    Sleep latency of MWT for MK-6552 compared with placebo

Secondary outcomes

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

    Time frame: At designated timepoints up to 24 hours postdose

    AUC for plasma MK-6552 from 0-24 hours postdose

  2. Concentration of plasma MK-6522 at Tmax following morning (AM) dose

    Time frame: Tmax following AM dose (at designated timepoints up to 24 hours postdose)

    Plasma concentration of MK-6552 at Tmax following AM dose

  3. Concentration of plasma MK-6522 at Tmax following afternoon (PM) dose

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

    Plasma concentration of MK-6552 at Tmax following PM dose

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

    Time frame: 8 hours

    C8h of plasma MK-6552 after first dose

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

    Time frame: 24 hours

    C24h of plasma MK-6552 after first dose

  6. MWT for Modafinil

    Time frame: 2 hours postdose

    Sleep latency of MWT for Modafinil compared with placebo

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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