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

NCT ID: NCT06619665

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-19

Study Completion Date

2024-07-16

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Narcolepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

MK-6552

Intervention Type DRUG

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

MK-6552 placebo

Intervention Type DRUG

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

Modafinil

Intervention Type DRUG

Modafinil tablet taken once orally

Modafinil placebo

Intervention Type DRUG

Modafinil placebo tablet taken once orally

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.

Group Type EXPERIMENTAL

MK-6552

Intervention Type DRUG

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

MK-6552 placebo

Intervention Type DRUG

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

Modafinil

Intervention Type DRUG

Modafinil tablet taken once orally

Modafinil placebo

Intervention Type DRUG

Modafinil placebo tablet taken once orally

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.

Group Type EXPERIMENTAL

MK-6552

Intervention Type DRUG

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

MK-6552 placebo

Intervention Type DRUG

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

Modafinil

Intervention Type DRUG

Modafinil tablet taken once orally

Modafinil placebo

Intervention Type DRUG

Modafinil placebo tablet taken once orally

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.

Group Type EXPERIMENTAL

MK-6552

Intervention Type DRUG

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

MK-6552 placebo

Intervention Type DRUG

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

Modafinil

Intervention Type DRUG

Modafinil tablet taken once orally

Modafinil placebo

Intervention Type DRUG

Modafinil placebo tablet taken once orally

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.

Group Type EXPERIMENTAL

MK-6552

Intervention Type DRUG

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

MK-6552 placebo

Intervention Type DRUG

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

Modafinil

Intervention Type DRUG

Modafinil tablet taken once orally

Modafinil placebo

Intervention Type DRUG

Modafinil placebo tablet taken once orally

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.

Group Type EXPERIMENTAL

MK-6552

Intervention Type DRUG

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

MK-6552 placebo

Intervention Type DRUG

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

Modafinil

Intervention Type DRUG

Modafinil tablet taken once orally

Modafinil placebo

Intervention Type DRUG

Modafinil placebo tablet taken once orally

Interventions

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MK-6552

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

Intervention Type DRUG

MK-6552 placebo

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

Intervention Type DRUG

Modafinil

Modafinil tablet taken once orally

Intervention Type DRUG

Modafinil placebo

Modafinil placebo tablet taken once orally

Intervention Type DRUG

Eligibility Criteria

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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:
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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NeuroTrials Research Inc (Site 0001)

Atlanta, Georgia, United States

Site Status

Clinilabs (Site 0003)

Eatontown, New Jersey, United States

Site Status

Countries

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United States

Related Links

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http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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MK-6552-003

Identifier Type: OTHER

Identifier Source: secondary_id

6552-003

Identifier Type: -

Identifier Source: org_study_id

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