A Clinical Study of MK-6552 and Modafinil in Healthy Men (MK-6552-005)

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-20

Study Completion Date

2023-11-20

Brief Summary

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The goal of this study is to learn what happens to MK-6552 in a person's body over time. Researchers will compare what happens to levels of MK-6552 in people's blood when it is taken with and without modafinil. Researchers also want to learn about the safety of MK-6552 taken with and without modafinil and if people tolerate it.

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Detailed Description

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Conditions

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Healthy Narcolepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MK-6552 + Modafinil

In Period 1, participants receive MK-6552 orally. In Period 2, participants receive MK-6552 orally plus low dose modafinil orally. In Period 3, participants receive MK-6552 orally plus high dose modafinil orally.

Group Type EXPERIMENTAL

MK-6552

Intervention Type DRUG

Oral administration

Modafinil

Intervention Type DRUG

Oral administration

Interventions

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MK-6552

Oral administration

Intervention Type DRUG

Modafinil

Oral administration

Intervention Type DRUG

Other Intervention Names

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Provigil®

Eligibility Criteria

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Inclusion Criteria

* Is in good health based on medical history and physical examination
* Has a body mass index ≥18 and ≤32 kg/m\^2, inclusive

Exclusion Criteria

* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has a history of cancer

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes