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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
9
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
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. Events are reported according to dose. The number of participants with ≥1 AE is reported.
Time frame: Up to ~34 weeks
Number of Participants Discontinuing Study Intervention Due to 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. Events are reported according to dose. The number of participants that discontinued study intervention due to AE(s) is reported.
Time frame: Up to ~34 weeks
Sleep Onset Latency Measured by the Maintenance of Wakefulness Test (MWT) Following 7 Days of MK-6554 Treatment
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 of daily repeated MK-6552 treatment is reported.
Time frame: 1 hour after Dose 1 and Dose 2 on Day 7
Area Under the Plasma Concentration-Time Curve of MK-6552 From Time Zero to Infinity (AUC0-∞)
The AUC0-∞ of MK-6554 was determined for arms receiving 2 oral doses spaced 6 hours apart.
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)
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FutureSearch Trials of Neurology ( Site 0004)
Austin, Texas, United States
The AUC0-24 of MK-6554 was determined for arms receiving 2 oral doses spaced 6 hours apart.
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, and 18 hours postdose
Maximum Concentration (Cmax) of MK-6552
The Cmax of MK-6554 was determined for arms receiving 2 oral doses spaced 6 hours apart.
Time frame: Day 1 Dose 1: Predose, 0.25, 0.5, 1, 2, 3, 4, and 6 hours postdose. Day 1 Dose 2: 0.25, 0.5, 1, 2, 3, 4, 6, 8, 18, 21 and 24 hours postdose
Time to Maximum Concentration (Tmax) of MK-6552
The Tmax of MK-6554 was determined for arms receiving 2 oral doses spaced 6 hours apart.
Time frame: Day 1 Dose 1: Predose, 0.25, 0.5, 1, 2, 3, 4, and 6 hours postdose. Day 1 Dose 2: 0.25, 0.5, 1, 2, 3, 4, 6, 8, 18, 21 and 24 hours postdose
Concentration of MK-6522 at 2 Hours Postdose (C2h)
The C2h of MK-6554 was determined for arms receiving 2 oral doses spaced 6 hours apart.
Time frame: Day 1 Dose 1: 2 hours postdose. Day 1 Dose 2: 2 hours postdose.
Concentration of MK-6522 at 6 Hours Postdose (C6h)
The C6h of MK-6554 was determined for arms receiving 2 oral doses spaced 6 hours apart.
Time frame: Day 1 Dose 1: 6 hours postdose
Concentration of MK-6522 at 18 Hours Postdose (C18h)
The C18h of MK-6554 was determined for arms receiving 2 oral doses spaced 6 hours apart.
Time frame: Day 1 Dose 2: 18 hours postdose
Apparent Oral Clearance (CL/F) of MK-6552
The CL/F of MK-6554 was determined for arms receiving 2 oral doses spaced 6 hours apart.
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
Apparent Volume of Distribution (Vz/F) of MK-6552
The Vz/F of MK-6554 was determined for arms receiving 2 oral doses spaced 6 hours apart.
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
Apparent Terminal Half-life (t½) of MK-6552
The apparent t½ of MK-6554 was determined for arms receiving 2 oral doses spaced 6 hours apart.
Time frame: Day 1 Dose 1: Predose, 0.25, 0.5, 1, 2, 3, 4, and 6 hours postdose. Day 1 Dose 2: 0.25, 0.5, 1, 2, 3, 4, 6, 8, 18, 21 and 24 hours postdose