MK-6552 for Narcolepsy

No longer recruiting at 4 trial locations

Overseen By Toll Free Number

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Hypertension, Cardiovascular, Renal, Hepatic, others

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called MK-6552 for people with Narcolepsy Type 1 (NT1), a sleep disorder marked by excessive daytime sleepiness and sudden muscle weakness (cataplexy). The study will first determine the drug's safety and tolerability with different doses in a single day, then evaluate its effects over several days. Participants will be divided into groups, with some receiving the actual medication and others a placebo (inactive substance). The trial seeks individuals diagnosed with NT1 who have experienced cataplexy, can sleep more than 6 hours on most nights, and do not have certain health conditions like high blood pressure or heart issues. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that MK-6552 is likely to be safe for humans?

Research shows that MK-6552 remains in the early testing stages for people with narcolepsy. In these initial studies, researchers focus on how well participants tolerate MK-6552, monitoring for any health changes or unusual lab results. As a new treatment, detailed safety information is limited. However, these early trials help determine if MK-6552 is safe enough for further testing at higher doses or over longer periods. Ensuring participant safety is a top priority, and researchers will closely monitor and address any serious side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional treatments for narcolepsy, which often include stimulants like modafinil or sodium oxybate, MK-6552 offers a novel approach by potentially providing quicker relief. Researchers are excited because MK-6552 is taken orally and its effects can be tailored based on individual safety and tolerability, potentially making it more adaptable than current options. Additionally, MK-6552's dosing flexibility could mean that patients experience benefits in just a single day, which is a significant advantage over existing therapies that might take longer to show results.

What evidence suggests that MK-6552 might be an effective treatment for narcolepsy?

Research has shown that MK-6552, which participants in this trial may receive, might help people with narcolepsy stay awake. In earlier studies, MK-6552 proved more effective than a placebo at keeping sleep-deprived healthy people awake. This suggests the drug could also benefit those with narcolepsy. Although early results on MK-6552's effects in people with narcolepsy are still emerging, its ability to help healthy individuals stay awake is promising. More research is needed to confirm its effectiveness for narcolepsy. ^{1 2 3 5 6}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I've slept more than 6 hours on most nights in the last month.

Has a baseline history of unequivocal cataplexy prior to initiation of anti-cataplexy medications

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

Exclusion Criteria

I do not have significant mental health issues that would affect my participation.

I have a significant sleep disorder like severe sleep apnea or insomnia.

I have a history of seizures, significant head injury, brain surgery, or serious memory loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1: Dose Escalation

Participants receive single oral doses of MK-6552 in ascending fashion approximately 6 hours apart for a single day to evaluate safety, tolerability, and pharmacokinetics.

1 day

1 visit (in-person)

Part 2: Multiple-Day Dosing

Participants receive multiple days of MK-6552 or placebo dosing (7 consecutive days) to investigate pharmacodynamics.

7 days

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment.

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MK-6552

Trial Overview 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.

How Is the Trial Designed?

Group I: MK-6552 Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06179407?cond=Narcolepsy%201&rank=10

Study of MK-6552 in Participants With Narcolepsy Type 1 ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. trial.medpath.com trial.medpath.com/clinical-trial/333e48c56448f4fe/nct06179407-safety-tolerability-pharmacokinetics-mk-6552-narcolepsy

Study of MK-6552 in Participants With Narcolepsy Type 1 (MK ... The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-6552 in participants with Narcolepsy ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06619665

A Study of MK-6552 in Sleep Deprived Healthy Participants ... This study examined the safety of the drug MK-6552 and if people tolerated it. It also studied whether MK-6552 works better than placebo for staying awake in ...

4. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06179407/

Trial | NCT06179407 The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-6552 in participants with Narcolepsy ...

5. merckclinicaltrials.com merckclinicaltrials.com/trial/nct06179407/

Study of MK-6552 in Participants With Narcolepsy Type 1 The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-6552 in participants with Narcolepsy ...

6. ctv.veeva.com ctv.veeva.com/study/study-of-mk-6552-in-participants-with-narcolepsy-type-1-mk6552004

Study of MK-6552 in Participants With Narcolepsy Type 1 (MK ... The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-6552 in participants ...