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Study of MK-6552 in Participants With Narcolepsy Type 1 (MK-6552-004)
Sponsor: Merck Sharp & Dohme LLC
Summary
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.
Official title: A Two-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Sleep Latency Effects of MK-6552 in Participants With Narcolepsy Type 1
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
9
Start Date
2024-01-24
Completion Date
2024-10-23
Last Updated
2026-04-14
Healthy Volunteers
No
Conditions
Interventions
MK-6552
Oral capsule
Placebo
Oral capsule matched to MK-6552
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
FutureSearch Trials of Neurology ( Site 0004)
Austin, Texas, United States