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

A vizsgálat adatai

Ki végzi

Merck Sharp & Dohme LLC

Azonosító

NCT06179407

A regiszteradat frissítve

2026. április 14.

Eredeti leírás

The purpose of this study was to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-6552 in participants with Narcolepsy Type 1 (NT1). The effect of single MK-6552 doses were assessed initially under open-label conditions to evaluate the safety, tolerability, and PK of MK-6552. The effect of repeated MK-6552 doses (every 8 hours [q8h] for 7 days) were assessed under double-blind and placebo-controlled conditions.A teljes eredeti leírásKevesebb

A Two-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Sleep Latency Effects of MK-6552 in Participants With Narcolepsy Type 1

The purpose of this study was to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-6552 in participants with Narcolepsy Type 1 (NT1). The effect of single MK-6552 doses were assessed initially under open-label conditions to evaluate the safety, tolerability, and PK of MK-6552. The effect of repeated MK-6552 doses (every 8 hours [q8h] for 7 days) were assessed under double-blind and placebo-controlled conditions.

Bevonási feltételek: 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.

Kizáró feltételek: 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; 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; 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.

ClinicalTrials.gov NCT06179407