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

Phase 1CompletedNCT06619665

Merck Sharp & Dohme LLC18 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy Narcolepsy

Interventions

MK-6552DRUG

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

MK-6552 placeboDRUG

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

ModafinilDRUG

Modafinil tablet taken once orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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:

Locations (2)

NeuroTrials Research Inc (Site 0001)

Atlanta, Georgia, United States

Clinilabs (Site 0003)

Eatontown, New Jersey, United States

Outcomes

Primary Outcomes

Participants with an Adverse Event (AE)

Percentage of participants with at least one AE

Time frame: Up to Day 30

Participants who discontinued from study due to an AE

Percentage of participants who discontinued from study due to an AE

Time frame: Day 1

Maintenance of Wakefulness Test (MWT) for MK-6552

Sleep latency of MWT for MK-6552 compared with placebo

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

Secondary Outcomes

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

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 8 hours

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

Data from ClinicalTrials.gov

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