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

NCT05651152 | Completed Phase 1 FDA Drug

• 1 other identifier: JZP441-101
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Participants

Keywords

Healthy Participants; JZP441

Outcome Measures

Primary Outcomes (1)

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

  1 hour postdose up to Day 8

Secondary Outcomes (3)

• 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

• Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP441

  Pre-dose and multiple post-dose timepoints, up to 36 hours

Study Arms (2)

JZP441

EXPERIMENTAL

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

Drug: JZP441

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

JZP441 DRUG

Nighttime oral dose

JZP441

Placebo DRUG

Nighttime oral dose

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Presence at Screening of human immunodeficiency virus (HIV) antibody, hepatitis B surface 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 for sleep apnea by standardized questionnaire (STOP-BANG)
• Any clinically relevant medical, behavioral, or psychiatric disorder that is associated with excessive sleepiness

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (2)

Clinical Site 1

Eatontown, New Jersey, 07724, United States

Location

Clinical Site 2

New York, New York, 10016, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind (participants and site staff \[excluding site pharmacy staff\])
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 14, 2022
• Study Start: November 28, 2022
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

US (2)