RecruitingPhase 2NCT06752668

A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia

A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ORX750 in Subjects With Narcolepsy and Idiopathic Hypersomnia (CRYSTAL-1)


Sponsor

Centessa Pharmaceuticals (UK) Limited

Enrollment

96 participants

Start Date

Dec 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), and Idiopathic Hypersomnia (IH) are rare conditions that make people feel very sleepy during the day (often referred to as excessive daytime sleepiness \[EDS\]). People living with these conditions might find it hard to stay alert and pay attention when they are at school, working, driving, or performing other daily activities. While all conditions result in feeling sleepy, there are some differences in other common symptoms: * NT1: People with NT1 often feel very tired during the day and experience cataplexy. Cataplexy is a sudden loss of muscle strength, which can cause someone to collapse or lose control of their muscles for a short time. This is often triggered by strong emotions, such as laughter or surprise. They may also have trouble sleeping well at night. * NT2: People with NT2 feel sleepy during the day, just like NT1, but they do not have cataplexy. * IH: People with IH feel tired during the day, even after sleeping a lot at night. They may sleep for long periods, take long naps, and find it hard to wake up. Orexin is a protein in the brain that helps coordinate a system that plays an important role in helping people to stay awake during the daytime. ORX750 is designed to mimic the action of orexin. The purpose of this study is to see how safe and tolerable ORX750 is in NT1, NT2, and IH, and learn about what the drug does to the body. Another goal of the study is to see if ORX750 can help people with NT1, NT2, and IH feel less sleepy and make other symptoms better.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • -65 years of age
  • BMI ≥17 and ≤37 kg/m2
  • Meets the diagnostic criteria of Narcolepsy Type 1 (NT1), Type 2 (NT2) or Idiopathic Hypersomnia (IH) according to ICSD-3-TR criteria
  • Is willing and able to discontinue all medications used for the treatment of narcolepsy or idiopathic hypersomnia
  • Is willing and able to adhere to additional protocol requirements

Exclusion Criteria2

  • A medical disorder other than NT1, NT2, or IH that is associated with excessive daytime sleepiness (EDS).
  • Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease

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Interventions

DRUGORX750

ORX750 capsule.

DRUGPlacebo

ORX750 matching placebo capsule.


Locations(29)

Auburn, Alabama

Auburn, Alabama, United States

Chandler, Arizona

Chandler, Arizona, United States

Scottsdale, Arizona

Scottsdale, Arizona, United States

Long Beach, California

Long Beach, California, United States

Santa Ana, California

Santa Ana, California, United States

Brandon, Florida

Brandon, Florida, United States

Miami, Florida

Miami, Florida, United States

Miami, Florida

Miami, Florida, United States

Orlando, FL

Orlando, Florida, United States

Winter Park, Florida

Winter Park, Florida, United States

Atlanta, Georgia

Atlanta, Georgia, United States

Atlanta, Georgia

Atlanta, Georgia, United States

Riverdale, Georgia

Riverdale, Georgia, United States

New Orleans, Louisiana

New Orleans, Louisiana, United States

Newton, Massachusetts

Newton, Massachusetts, United States

Southfield, Michigan

Southfield, Michigan, United States

Sterling Heights, Michigan

Sterling Heights, Michigan, United States

Henderson, Nevada

Henderson, Nevada, United States

Denver, North Carolina

Denver, North Carolina, United States

Huntersville, North Carolina

Huntersville, North Carolina, United States

Cincinnati, Ohio

Cincinnati, Ohio, United States

Cleveland, OH

Cleveland, Ohio, United States

Dublin, Ohio

Dublin, Ohio, United States

Willow Grove, Pennsylvania

Willow Grove, Pennsylvania, United States

Columbia, South Carolina

Columbia, South Carolina, United States

North Charleston, South Carolina

North Charleston, South Carolina, United States

Austin, Texas

Austin, Texas, United States

San Antonio, Texas

San Antonio, Texas, United States

Toronto, Ontario

Toronto, Ontario, Canada

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NCT06752668


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