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| ID | Type | Description | Link |
|---|---|---|---|
| MK-6554-004 | Other Identifier | MSD |
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Terminated for business reasons
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A | Experimental | Participants will receive single oral doses of MK-6552 in ascending fashion approximately 6 hours apart for a single day, based on safety and tolerability of the previous dose. Then, participants will receive multiple days of MK-6552 dosing (7 consecutive days) at the highest safe and well tolerated MK-6552 dose determined on an individual basis from Part 1. |
|
| Panel B | Experimental | Panel B will assess the effects of repeated MK-6552 dosing across a range of doses compared with placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-6552 | Drug | Oral capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 1 hour after Dose 1 and Dose 2 on Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Delta Waves, Inc. ( Site 0008) | Colorado Springs | Colorado | 80918 | United States | ||
| Teradan Clinical Trials, LLC ( Site 0005) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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Adult participants with narcolepsy type 1 were enrolled at 5 study sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Panel A | Participants received a single dose (0.1, 0.25, 0.5 and 1 mg) of MK-6552 twice on a single day, with each dose separated by ≥4 days of washout. Participants then received MK-6552 1 mg (1 participant received MK-6552 0.1 mg) or placebo for 7 days in a counter-balanced order. Two days of washout separated the repeated treatments, and there were 14 days of follow-up post-treatment. |
| FG001 | Panel B | Panel B was not initiated due to early study termination. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Single Doses (Days 1 to 16) |
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| Single Dose Washout (Days 17 to 20) |
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| Repeated Treatment 1 (Days 21 to 29) |
| |||||||||||||||||||||||||||||||
| Repeated Treatment 2 (Days 30 to 51) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Panel A | Participants received a single dose (0.1, 0.25, 0.5 and 1 mg) of MK-6552 twice on a single day, with each dose separated by ≥4 days of washout. Participants then received MK-6552 1 mg (1 participant received MK-6552 0.1 mg) or placebo for 7 days in a counter-balanced order. Two days of washout separated the repeated treatments, and there were 14 days of follow-up post-treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | All treated participants who received 2 oral doses spaced 6 hours apart and have data available are included. | Posted | Geometric Mean | 95% Confidence Interval | hr*nmol/L | 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 |
|
Up to ~34 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-6552 0.1 mg | Participants received 2 oral doses of MK-6552 0.1 mg spaced 6 hours apart, followed by ≥4 days of follow-up. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA 27.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 5, 2024 | Oct 14, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| Drug |
Oral capsule matched to MK-6552 |
|
| Area Under the Plasma Concentration-Time Curve of MK-6552 From Time Zero to 24 Hours Postdose (AUC0-24) |
The AUC0-24 of MK-6554 was determined for arms receiving 2 oral doses spaced 6 hours apart. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 |
| Brandon |
| Florida |
| 33511 |
| United States |
| NeuroTrials Research Inc ( Site 0006) | Atlanta | Georgia | 30328 | United States |
| Bogan Sleep Consultants ( Site 0001) | Columbia | South Carolina | 29201 | United States |
| FutureSearch Trials of Neurology ( Site 0004) | Austin | Texas | 78731 | United States |
| NOT COMPLETED |
|
|
| Placebo x 7 Days + 2-Day Washout |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| MK-6552 0.1 mg x 7 Days + 2-Day Washout |
|
| Placebo x 7 Days + 2-Day Washout |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants received 2 oral doses of MK-6552 0.25 mg spaced 6 hours apart, followed by ≥4 days of follow-up.
| OG002 | MK-6552 0.5 mg | Participants received 2 oral doses of MK-6552 0.5 mg spaced 6 hours apart, followed by ≥4 days of follow-up. |
| OG003 | MK-6552 1 mg | Participants received 2 oral doses of MK-6552 1 mg spaced 6 hours apart, followed by ≥4 days of follow-up. |
| OG004 | MK-6552 1 mg x 7 Days | Participants received oral doses of MK-6552 1 mg q8h for 7 days followed by ≥4 days of follow-up. |
| OG005 | MK-6552 0.1 mg x 7 Days | Participants received oral doses of MK-6552 1 mg q8h for 7 days followed by ≥4 days of follow-up. |
| OG006 | Placebo x 7 Days | Participants received oral doses of placebo q8h for 7 days followed by ≥4 days of follow-up. |
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve of MK-6552 From Time Zero to 24 Hours Postdose (AUC0-24) | The AUC0-24 of MK-6554 was determined for arms receiving 2 oral doses spaced 6 hours apart. | All treated participants who received 2 oral doses spaced 6 hours apart and have data available are included.. | Posted | Geometric Mean | 95% Confidence Interval | hr*nmol/L | 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 |
|
|
|
| Secondary | Maximum Concentration (Cmax) of MK-6552 | The Cmax of MK-6554 was determined for arms receiving 2 oral doses spaced 6 hours apart. | All treated participants who received 2 oral doses spaced 6 hours apart and have data available are included. | Posted | Geometric Mean | 95% Confidence Interval | nmol/L | 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 |
|
|
|
| Secondary | 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. | All treated participants who received 2 oral doses spaced 6 hours apart and have data available are included. | Posted | Median | Full Range | hours | 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 |
|
|
|
| Secondary | 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. | All treated participants who received 2 oral doses spaced 6 hours apart and have data available are included. | Posted | Geometric Mean | 95% Confidence Interval | nmol/L | Day 1 Dose 1: 2 hours postdose. Day 1 Dose 2: 2 hours postdose. |
|
|
|
| Secondary | 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. | All treated participants who received 2 oral doses spaced 6 hours apart and have data available are included. | Posted | Geometric Mean | 95% Confidence Interval | nmol/L | Day 1 Dose 1: 6 hours postdose |
|
|
|
| Secondary | 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. | All treated participants who received 2 oral doses spaced 6 hours apart and have data available are included. | Posted | Geometric Mean | 95% Confidence Interval | nmol/L | Day 1 Dose 2: 18 hours postdose |
|
|
|
| Secondary | 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. | All treated participants who received 2 oral doses spaced 6 hours apart and have data available are included. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters/hour | 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 |
|
|
|
| Secondary | 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. | All treated participants who received 2 oral doses spaced 6 hours apart and have data available are included. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | 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 |
|
|
|
| Secondary | 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. | All treated participants who received 2 oral doses spaced 6 hours apart and have data available are included. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | 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 |
|
|
|
| Primary | 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. | All treated participants are included. | Posted | Count of Participants | Participants | Up to ~34 weeks |
|
|
|
| Primary | 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. | All treated participants are included. | Posted | Count of Participants | Participants | Up to ~34 weeks |
|
|
|
| Primary | 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. | All treated participants who received 7 days treatment with either MK-6552 0.1 mg or 1 mg or placebo are included. | Posted | Mean | 95% Confidence Interval | minutes | 1 hour after Dose 1 and Dose 2 on Day 7 |
|
|
|
| 3 |
| 9 |
| 0 |
| 9 |
| 3 |
| 9 |
| EG001 | MK-6552 0.25 mg | Participants received 2 oral doses of MK-6552 0.25 mg spaced 6 hours apart, followed by ≥4 days of follow-up. | 2 | 8 | 0 | 8 | 2 | 8 |
| EG002 | MK-6552 0.5 mg | Participants received 2 oral doses of MK-6552 0.5 mg spaced 6 hours apart, followed by ≥4 days of follow-up. | 1 | 7 | 0 | 7 | 1 | 7 |
| EG003 | MK-6552 1 mg | Participants received 2 oral doses of MK-6552 1 mg spaced 6 hours apart, followed by ≥4 days of follow-up. | 1 | 7 | 0 | 7 | 1 | 7 |
| EG004 | MK-6552 1 mg x 7 Days | Participants received oral doses of MK-6552 1 mg q8h for 7 days followed by ≥4 days of follow-up. | 2 | 6 | 0 | 6 | 2 | 6 |
| EG005 | MK-6552 0.1 mg x 7 Days | Participants received oral doses of MK-6552 0.1 mg q8h for 7 days followed by ≥4 days of follow-up. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG006 | Placebo x 7 Days | Participants received oral doses of placebo q8h for 7 days followed by ≥4 days of follow-up. | 1 | 7 | 0 | 7 | 1 | 7 |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Feeling abnormal | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
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If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| Day 1 Dose 2 |
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| Day 1 Dose 2 |
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| Day 1 Dose 2 |
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| 1 Hour after Dose 2 |
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