A Study to Investigate The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP441 in Sleep-deprived Healthy Participants

Last updated: July 29, 2024
Sponsor: Jazz Pharmaceuticals
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

Placebo

JZP441

Clinical Study ID

NCT05651152
JZP441-101
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This Phase 1, double-blind, randomized, placebo-controlled study will characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ascending nighttime doses of JZP441 in sleep-deprived healthy participants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 to 50 years of age inclusive, at the time of signing the informed consent

  • Are overtly healthy as determined by medical evaluation, including medical history,physical exam, laboratory tests, and cardiac/blood pressure monitoring

Exclusion

Exclusion Criteria:

  • Female participants who are pregnant, nursing, or lactating

  • History or presence of clinically significant allergy or allergy to band aids,adhesive dressing, electrocardiogram (ECG) patches, or medical tape

  • History or presence of gastrointestinal (including prior bariatric bypass surgery),hepatic or renal disease, or any other condition that may interfere with absorption,distribution, metabolism, or excretion of drugs

  • Presence of renal impairment or calculated creatinine clearance < 80 mL/min

  • Triplicate 12-lead ECG demonstrating a mean QTcF > 450 msec for males and > 470 msecfor females or any other clinically significant ECG abnormality per investigatorassessment at Screening or Day -1

  • Presence or history of significant cardiovascular disease including but not limitedto: myocardial infarction, uncontrolled hypertension, systolic blood pressure > 140mmHg or diastolic blood pressure > 90 mmHg (at Screening or Day -1), anginapectoris, clinically significant arrhythmias, clinically significant valvular heartdisease, history of any revascularization procedures or second or third-degree heartblock with/without a pacemaker, heart failure, or family history of Torsades dePointes

  • Laboratory value(s) outside the laboratory reference range that are considered to beclinically significant by the investigator

  • Current diagnosis of or receiving treatment for depression; past (within 5 years)major depressive episode according to Diagnostic and Statistical Manual of MentalDisorders-5 (DSM-5) criteria; history of suicide attempt, current suicidal risk asdetermined from history, or presence of active suicidal ideation

  • History or presence of bipolar disorder, bipolar related disorders, schizophrenia,schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5criteria

  • Participation in another clinical study of an investigational drug or medical devicewithin 30 days or 5 half-lives (whichever is longer) prior to check-in on Day -1

  • Presence at Screening of human immunodeficiency virus (HIV) antibody, hepatitis Bsurface antigen, hepatitis C antibody, or a clinical history of these infections

  • History of chronic insomnia (as defined by DSM-5 criteria)

  • Has been diagnosed with sleep apnea or been identified as being at high risk forsleep apnea by standardized questionnaire (STOP-BANG)

  • Any clinically relevant medical, behavioral, or psychiatric disorder that isassociated with excessive sleepiness

Study Design

Total Participants: 105
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
November 28, 2022
Estimated Completion Date:
November 15, 2023

Study Description

This study will initially employ nighttime dosing in sleep-deprived healthy participants. Participants (up to 12 per cohort) will be randomized to study intervention. Participants will remain awake during the day and then will be dosed at night. Safety, tolerability, PK and PD assessments will be conducted for nighttime dose.

Connect with a study center

  • Clinical Site 1

    Eatontown, New Jersey 07724
    United States

    Site Not Available

  • Clinical Site 2

    New York, New York 10016
    United States

    Site Not Available

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