← Back to Search

Orexin Receptor Antagonist

MK-6552 for Narcolepsy

Phase 1

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is positive for HLA-DQB1*06:02 allele supporting a diagnosis of NT1

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

Study Summary

This trial aims to assess the safety, effectiveness, and how the drug is processed and behaves in the body of participants with Narcolepsy Type 1. The study will be in two parts, with

Who is the study for?

This trial is for individuals with Narcolepsy Type 1 (NT1), who have had a valid sleep study in the last 5 years and been diagnosed with NT1 for at least 6 months. They must sleep over 6 hours on most nights and be positive for a specific genetic marker (HLA-DQB1*06:02). Participants should also have a history of cataplexy before starting any related medications.Check my eligibility

What is being tested?

The trial is testing MK-6552, which could potentially treat NT1. The first part checks how safe it is and how the body processes different doses in one day. The second part looks at how well it works after taking it once or multiple times across several days. Some participants will receive a placebo instead to compare results.See study design

What are the potential side effects?

While the side effects are not detailed here, common ones may include reactions where the drug enters the body, changes in alertness, stomach issues, or headaches. Side effects can vary widely from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have the HLA-DQB1*06:02 allele, indicating narcolepsy type 1.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Number of participants experiencing an Adverse Event (AE)

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

Secondary outcome measures

Apparent Oral Clearance (CL/F) of MK-6552

Apparent Terminal Half-life (t½) of MK-6552

Apparent Volume of Distribution (Vz/F) of MK-6552

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MK-6552Experimental Treatment1 Intervention

In Part 1, 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. In Part 2, 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.

Group II: PlaceboPlacebo Group1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,892 Previous Clinical Trials

5,061,134 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,064,392 Total Patients Enrolled

4 Trials studying Narcolepsy

342 Patients Enrolled for Narcolepsy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the criteria to participate in this medical study?

"To qualify for participation in this investigation, individuals must have a diagnosis of narcolepsy and fall within the age range of 18 to 55. A total of 12 participants will be enrolled in this research endeavor."

Answered by AI

What is the current number of participants being enrolled in this research investigation?

"Indeed, information from clinicaltrials.gov indicates that this research study is actively seeking volunteers. It was initially published on January 24th, 2024, and last revised on February 5th, 2024. The trial aims to enroll a total of 12 participants at one specific location."

Answered by AI

Are there ongoing efforts to actively enroll participants for this clinical trial?

"Yes, the information on clinicaltrials.gov shows that this research is actively enrolling subjects. The trial was first listed on January 24th, 2024 and last revised on February 5th, 2024. Recruitment aims to find 12 participants at one designated site."

Answered by AI

Are individuals above the age of 35 eligible to participate in this clinical trial?

"Eligible participants for this study must be over 18 years of age but under the age of 55."

Answered by AI

What is the primary goal of conducting this scientific study?

"The primary aim of this clinical research, to be assessed over an approximate duration of up to 7 weeks, is the number of participants discontinuing the study intervention due to adverse events (AE). Secondary endpoints include Concentration of MK-6522 at 6 Hours Postdose (C6h), which involves collecting blood samples at specific intervals for C6h determination. Additionally, Apparent Oral Clearance (CL/F) of MK-6552 will be evaluated by analyzing blood samples for CL/F calculation. Another secondary outcome is Concentration of MK-6522 at 18 Hours Postdose (C18h), where blood samples"

Answered by AI

Has MK-6552 received approval from the FDA?

"According to our assessment at Power, the safety rating for MK-6552 is a 1 on a scale of 1 to 3. This reflects the early Phase 1 nature of the trial and limited available data supporting its safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Study of MK-6552 in Participants With Narcolepsy Type 1 (MK-6552-004)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06179407.

All > Paid Studies Atlanta > Colorado Springs