Phase
Condition
N/ATreatment
Placebo
JZP441
Clinical Study ID
Ages 18-50 All Genders Accepts Healthy Volunteers
Study Summary
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
Study Description
Connect with a study center
Clinical Site 1
Eatontown, New Jersey 07724
United StatesSite Not Available
Clinical Site 2
New York, New York 10016
United StatesSite Not Available
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