NCT06179407

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study was terminated by the Sponsor on 15OCT2024 out of an abundance of caution regarding elevations in liver function tests in 3 participants (all cases were asymptomatic and none met Hy's law for drug-induced liver injury or SAE criteria).

Conditions

• Narcolepsy

Interventions

Type	Name	Description
DRUG	MK-6552	Oral capsule
DRUG	Placebo	Oral capsule matched to MK-6552

Timeline

• Start date: 2024-01-24
• Primary completion: 2024-10-23
• Completion: 2024-10-23
• First posted: 2023-12-21
• Last updated: 2026-04-14
• Results posted: 2026-04-14

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study