Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Nighttime Doses of JZP441 in Sleep-Deprived Healthy Participants: A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study

Jazz Pharmaceuticals2 sites in 1 country105 target enrollmentNovember 28, 2022

ConditionsHealthy Participants

InterventionsJZP441 Placebo

Overview

Phase: Phase 1
Intervention: JZP441
Conditions: Healthy Participants
Sponsor: Jazz Pharmaceuticals
Enrollment: 105
Locations: 2
Primary Endpoint: Number of Participants With Treatment-emergent Adverse Events After Administration of JZP441 in Sleep-deprived Healthy Participants
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

November 28, 2022

End Date

November 15, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jazz Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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 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 msec for females or any other clinically significant ECG abnormality per investigator assessment at Screening or Day -1
•Presence or history of significant cardiovascular disease including but not limited to: myocardial infarction, uncontrolled hypertension, systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg (at Screening or Day -1), angina pectoris, clinically significant arrhythmias, clinically significant valvular heart disease, history of any revascularization procedures or second or third-degree heart block with/without a pacemaker, heart failure, or family history of Torsades de Pointes
•Laboratory value(s) outside the laboratory reference range that are considered to be clinically 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 Mental Disorders-5 (DSM-5) criteria; history of suicide attempt, current suicidal risk as determined 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-5 criteria
•Participation in another clinical study of an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) prior to check-in on Day -1

Arms & Interventions

JZP441

Participants who will be randomized to receive an oral dose of JZP441.

Intervention: JZP441

Placebo

Participants who will be randomized to receive an oral dose of placebo.

Intervention: Placebo

Outcomes

Primary Outcomes

Number of Participants With Treatment-emergent Adverse Events After Administration of JZP441 in Sleep-deprived Healthy Participants

Time Frame: 1 hour postdose up to Day 8

Secondary Outcomes

Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP441(Pre-dose and multiple post-dose timepoints, up to 36 hours)
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) Levels of JZP441(Pre-dose and multiple post-dose timepoints, up to 36 hours)
Pharmacokinetic Parameter Time to Maximum Plasma Concentration (Tmax) of JZP441(Pre-dose and multiple post-dose timepoints, up to 36 hours)