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

Phase 1TerminatedNCT06179407

Merck Sharp & Dohme LLC9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Narcolepsy

Interventions

MK-6552DRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (5)

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

Outcomes

Primary Outcomes

Number of participants experiencing an Adverse Event (AE)

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experience an AE will be reported.

Time frame: Up to approximately 9 weeks

Number of participants discontinuing study intervention due to an Adverse Event (AE)

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants that discontinue study intervention due to an AE will be reported.

Time frame: Up to approximately 7 weeks

Sleep Onset Latency Measured by the Maintenance of Wakefulness Test (MWT)

The MWT is a daytime polysomnographic procedure that measures objectively the ability to remain awake during sleep-inducing circumstances. Sleep onset latency is defined as the first occurrence of sustained sleep (i.e. 3 consecutive 30 second epochs of N1 \[stage 1\] sleep or any single 30 second epoch of N2 \[stage 2\], N3 \[stage 3 and 4 combined\] or REM). The primary outcome measure of sleep onset latency measured by the MWT on Day 7 will be reported.

Time frame: 1 hour after each dose on Day 7

Secondary Outcomes

Area Under the Plasma Concentration-Time Curve of MK-6552 from Time Zero to infinity (AUC0-inf)

Blood samples will be collected at specified intervals for the determination of AUC0-inf. AUC0-inf is defined as the area under the concentration-time curve of MK-6552 from time zero to infinity and will be reported for participants in Part 1.

Time frame: Day 1 Dose 1: Predose, 0.25, 0.5, 1, 2, 3, 4, and 6 hours postdose 1. Day 1 Dose 2: 0.25, 0.5, 1, 2, 3, 4, 6, 8, 18, 21 and 24 hours postdose

Area Under the Plasma Concentration-Time Curve of MK-6552 from Time Zero to 24 hours postdose (AUC0-24)

Data from ClinicalTrials.gov

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