Study of MK-6552 in Participants With Narcolepsy Type 1 (MK-6552-004)

NCT ID: NCT06179407

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-24
• Study Completion Date: 2024-10-23

Brief Summary

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-6552 in participants with Narcolepsy Type 1 (NT1). Part 1 will evaluate safety, tolerability, and PK of MK-6552 after administration of ascending doses in a single day to support a dose level decision for Part 2. Part 2 will investigate the PD of MK-6552 after single-day and multiple-day administration. Participants who complete Part 1 and demonstrate that they are able to tolerate at least one dose level of MK-6552 will participate in Part 2.

Conditions

Narcolepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MK-6552

In Part 1, participants will receive single oral doses of MK-6552 in ascending fashion approximately 6 hours apart for a single day, based on safety and tolerability of the previous dose. In Part 2, participants will receive multiple days of MK-6552 dosing (7 consecutive days) at the highest safe and well tolerated MK-6552 dose determined on an individual basis from Part 1.

Group Type: EXPERIMENTAL

MK-6552

Intervention Type: DRUG

Oral capsule administered according to allocation (Part 1)/randomization (Part 2).

Placebo

In Part 2, participants will receive multiple days of placebo dosing (7 consecutive days).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

In Part 2, participants will receive multiple days of placebo dosing (7 consecutive days).

Interventions

MK-6552

Oral capsule administered according to allocation (Part 1)/randomization (Part 2).

Intervention Type: DRUG

Placebo

In Part 2, participants will receive multiple days of placebo dosing (7 consecutive days).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Has a diagnosis of NT1, including a valid polysomnography within the previous 5 years and a current diagnosis of NT1 for at least 6 months based on criteria established by the International Classification of Sleep Disorders- Third Edition, or Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) [American Psychiatric Association 2013]
• Is positive for HLA-DQB1*06:02 allele supporting a diagnosis of NT1
• Has a baseline history of unequivocal cataplexy prior to initiation of anti-cataplexy medications
• Reports a total sleep time of > 6 hours on at least 4 out of 7 nights each week within the 4 weeks prior to screening visit

Exclusion Criteria

• Has history of or current hypertension
• Has underlying cardiovascular or cerebrovascular conditions in which an acute rise in blood pressure would pose a clinical concern, including but nor limited to aneurysms or arteriovenous malformations
• Has a history of renal or hepatic impairment
• Has a history of cardiac ischemia or cerebral ischemia including but not limited to history of stroke, transient ischemic attack, or transient global amnesia
• Based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale, is at imminent risk of self-harm or of harm to others in the opinion of the investigator
• Mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years
• History of cancer (malignancy)
• Has a history of any of the following sleep disorders: obstructive sleep apnea (OSA) defined as an Apnea Hypopnea Index > 15 per hour per the American Academy of Sleep Medicine alternate criteria, primary insomnia (within the past 6 months), circadian rhythm sleep disorder, shift work sleep disorder (within the past 6 months), clinically significant parasomnia at the discretion of the investigator
• Has a history of seizure disorder, clinically significant head trauma, or past invasive intracranial surgery or clinically significant dementia
• Positive test(s) for Hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Delta Waves, Inc. ( Site 0008)

Colorado Springs, Colorado, United States

Teradan Clinical Trials, LLC ( Site 0005)

Brandon, Florida, United States

NeuroTrials Research Inc ( Site 0006)

Atlanta, Georgia, United States

Bogan Sleep Consultants ( Site 0001)

Columbia, South Carolina, United States

FutureSearch Trials of Neurology ( Site 0004)

Austin, Texas, United States

Countries

United States

Related Links

http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

MK-6554-004

Identifier Type: OTHER

Identifier Source: secondary_id

6552-004

Identifier Type: -

Identifier Source: org_study_id