MK-6552 for Narcolepsy

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

9 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

This trial tests a new drug, MK-6552, for safety and effectiveness in people with Narcolepsy Type 1. It aims to understand how the drug behaves in the body and its impact on the sleep disorder.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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