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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06619665

Enrollment

Registered

2024-10-01

Start date

2024-03-19

Completion date

2024-07-16

Last updated

2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Narcolepsy

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.

Interventions

DRUGMK-6552

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

DRUGMK-6552 placebo

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

DRUGModafinil

Modafinil tablet taken once orally

DRUGModafinil placebo

Modafinil placebo tablet taken once orally

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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:

Design outcomes

Primary

Measure	Time frame	Description
Participants with an Adverse Event (AE)	Up to Day 30	Percentage of participants with at least one AE
Participants who discontinued from study due to an AE	Day 1	Percentage of participants who discontinued from study due to an AE
Maintenance of Wakefulness Test (MWT) for MK-6552	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

Measure	Time frame	Description
Concentration of plasma MK-6552 8 hours (C8h) after first dose	8 hours	C8h of plasma MK-6552 after first dose
Area under the concentration=time curve (AUC) for plasma MK-6552	At designated timepoints up to 24 hours postdose	AUC for plasma MK-6552 from 0-24 hours postdose
MWT for Modafinil	2 hours postdose	Sleep latency of MWT for Modafinil compared with placebo
Concentration of plasma MK-6552 24 hours (C24h) after first dose	24 hours	C24h of plasma MK-6552 after first dose
Concentration of plasma MK-6522 at Tmax following morning (AM) dose	Tmax following AM dose (at designated timepoints up to 24 hours postdose)	Plasma concentration of MK-6552 at Tmax following AM dose
Concentration of plasma MK-6522 at Tmax following afternoon (PM) dose	Tmax following PM dose (at designated timepoints up to 24 hours postdose)	Plasma concentration of MK-6552 at Tmax following PM dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026