Healthy ParticipantsPhase 1NCT05720494
A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JZP441 in Healthy Participants
A Phase 1 study testing JZP441 in people with Healthy Participants, run by Jazz Pharmaceuticals at 1 site in United States.
Trial summary
Treatments for narcolepsy and hypersomnolence disorders should have good oral bioavailability and brain penetration properties. JZP441 has demonstrated wake-promoting efficacy and anticataplectic activity in nonclinical studies and may represent a novel approach for these patients. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- JZP441
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2023to 29 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is 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.
Who cannot join
- History or presence of gastrointestinal (including prior bariatric bypass surgery), hepatic or renal disease, or any other condition that, in the investigator opinion, may interfere with absorption, distribution, metabolism, or excretion of drugs
- Presence of renal impairment or calculated eGFR < 80 mL/min/1.73 m^2.
- 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 prior to dose of study intervention
- Presence or history of significant cardiovascular disease including (but not limited to): myocardial infarction, uncontrolled hypertension, systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg (at Screening or baseline consistent with protocol specifications), 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
- Current diagnosis of or receiving treatment for depression; past (within 5 years) clinically significant major depressive episode; history of suicide attempt, current suicidal risk as determined from history, or presence of active suicidal ideation as indicated by a positive response to item 4 or item 5 on the C-SSRS (within the past 6 months)
- History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or clinically significant psychiatric disorders, including other psychotic disorders
Show all 16Show fewer
- History (within past 2 years at Screening) or presence of substance use disorder (including alcohol) or seeking treatment for alcohol or substance abuse related disorder
- History of seizure disorder or a physical condition that would increase seizure risk
- History of head trauma or concussions that are deemed clinically significant by the investigator
- Have used tobacco products or products for smoking cessation within 90 days before screening, including nicotine-containing products, or history of significant use of tobacco (> 10 cigarettes or equivalent per day) within 1 year before Screening, or unwilling to refrain from nicotine-containing products for the duration of the study
- Participants who are taking a concomitant medication or supplement that lowers seizure threshold (eg, kratom)
- Participants who have recently (< 2 weeks) discontinued a drug or supplement for which discontinuation would lower seizure threshold (eg, benzodiazepine medication)
- Participation in a previous JZP441 clinical study
- Positive alcohol test or urine drug screen (including cannabinoids and cotinine) at Screening or at any point throughout the duration of the study
- Presence at Screening of HIV antibody, Hepatitis B surface antigen, Hepatitis C antibody, or a clinical history of these infections
- History of clinically significant acute or chronic insomnia within the last 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of JZP441 in Healthy Adult Participants: A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study
Treatments for narcolepsy and hypersomnolence disorders should have good oral bioavailability and brain penetration properties. JZP441 has demonstrated wake-promoting efficacy and anticataplectic activity in nonclinical studies and may represent a novel approach for these patients.
Read the detailed description
This Phase 1, double-blind, randomized, placebo-controlled, parallel group study is designed to characterize the safety, tolerability, and PK of multiple ascending doses of JZP441 for up to 4 weeks in healthy adult participants.
- Conditions
- Healthy Participants
- Being tested
- JZP441, Placebo
- Keywords
- Healthy Participants, JZP441
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JZP441Drug
Oral study drug administered for up to 4 weeks
PlaceboDrug
Oral placebo administered for up to 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| JZP441 | Experimental | Healthy participants who will be randomized to receive an oral dose of JZP441. Receives: Drug: JZP441 |
| Placebo | Placebo comparator | Healthy participants who will be randomized to receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events
Measured: Day 1 up until 38 days after last dose of study drug, up to approximately 2 months
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) Levels of JZP441
Measured: Pre-dose and multiple post-dose timepoints, up to Day 28
Pharmacokinetic Parameter Time to Maximum Plasma Concentration (Tmax) of JZP441
Time to maximum plasma concentration (Tmax), time of maximum observed plasma concentration post first dose but before second dose during the 24-hour dosing interval (Tmax1), and time of maximum observed plasma concentration post second dose during the 24-hour dosing interval (Tmax2), and time of last quantifiable concentration (Tlast) will be assessed.
Measured: Pre-dose and multiple post-dose timepoints, up to Day 28
Pharmacokinetic Parameter Terminal Elimination Half-life (T1/2) of JZP441
Measured: Pre-dose and multiple post-dose timepoints, up to Day 28
Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP441
Area under the concentration-time curve from time 0 to 24 hours (AUC0-24), area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC0-last), and area under the concentration-time curve from time zero extrapolated to infinity (AUC∞) will be assessed.
Measured: Pre-dose and multiple post-dose timepoints, up to Day 28
Pharmacokinetic Parameter Apparent Oral Clearance (CL/F) of JZP441
Measured: Pre-dose and multiple post-dose timepoints, up to Day 28
Pharmacokinetic Parameter Apparent Volume of Distribution (Vz/F) of JZP441
Measured: Pre-dose and multiple post-dose timepoints, up to Day 28
Pharmacokinetic Parameter Accumulation Ratio of JZP441
Accumulation ratio (Cmax) and accumulation ratio (AUC) will be assessed.
Measured: Pre-dose and multiple post-dose timepoints, up to Day 28
Dose Proportionality of JZP441 for Maximum Concentration (Cmax)
Dose proportionality of maximum concentration (Cmax), maximum observed plasma concentration post first dose but before second dose during the 24-hour dosing interval (Cmax1), and maximum observed plasma concentration post second dose during the 24-hour dosing interval (Cmax2) will be assessed.
Measured: Pre-dose and multiple post-dose timepoints, up to Day 28
Dose Proportionality of JZP441 for Area Under the Concentration-Time Curve (AUC)
Dose proportionality of area under the concentration-time curve from 0 to 24 hours (AUC[0-24]) will be assessed.
Measured: Pre-dose and multiple post-dose timepoints, up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start26 Jan 2023
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720494
- Sponsor's protocol ID
- JZP441-102
- Status last verified
- Sep 2024
- First submitted
- 31 Jan 2023
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of JZP441 in Healthy Adult Participants: A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study
- ClinicalTrials.gov ID
- NCT05720494
- Acronym / sponsor ID
- JZP441-102
- Conditions
- Healthy Participants
- Keywords
- Healthy Participants, JZP441
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatments for narcolepsy and hypersomnolence disorders should have good oral bioavailability and brain penetration properties. JZP441 has demonstrated wake-promoting efficacy and anticataplectic activity in nonclinical studies and may represent a novel approach for these patients.
Detailed description
This Phase 1, double-blind, randomized, placebo-controlled, parallel group study is designed to characterize the safety, tolerability, and PK of multiple ascending doses of JZP441 for up to 4 weeks in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JZP441 | Experimental | Drug: JZP441Healthy participants who will be randomized to receive an oral dose of JZP441. |
| Placebo | Placebo comparator | Drug: PlaceboHealthy participants who will be randomized to receive placebo. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Is 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.
Key exclusion criteria (16 listed)
- History or presence of gastrointestinal (including prior bariatric bypass surgery), hepatic or renal disease, or any other condition that, in the investigator opinion, may interfere with absorption, distribution, metabolism, or excretion of drugs
- Presence of renal impairment or calculated eGFR < 80 mL/min/1.73 m^2.
- 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 prior to dose of study intervention
- Presence or history of significant cardiovascular disease including (but not limited to): myocardial infarction, uncontrolled hypertension, systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg (at Screening or baseline consistent with protocol specifications), 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
- Current diagnosis of or receiving treatment for depression; past (within 5 years) clinically significant major depressive episode; history of suicide attempt, current suicidal risk as determined from history, or presence of active suicidal ideation as indicated by a positive response to item 4 or item 5 on the C-SSRS (within the past 6 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JZP441Oral study drug administered for up to 4 weeks | Drug | JZP441 |
| PlaceboOral placebo administered for up to 4 weeks | Drug | Placebo |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events
Time frame: Day 1 up until 38 days after last dose of study drug, up to approximately 2 months
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) Levels of JZP441
Time frame: Pre-dose and multiple post-dose timepoints, up to Day 28
Pharmacokinetic Parameter Time to Maximum Plasma Concentration (Tmax) of JZP441
Time frame: Pre-dose and multiple post-dose timepoints, up to Day 28
Time to maximum plasma concentration (Tmax), time of maximum observed plasma concentration post first dose but before second dose during the 24-hour dosing interval (Tmax1), and time of maximum observed plasma concentration post second dose during the 24-hour dosing interval (Tmax2), and time of last quantifiable concentration (Tlast) will be assessed.
Pharmacokinetic Parameter Terminal Elimination Half-life (T1/2) of JZP441
Time frame: Pre-dose and multiple post-dose timepoints, up to Day 28
Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP441
Time frame: Pre-dose and multiple post-dose timepoints, up to Day 28
Area under the concentration-time curve from time 0 to 24 hours (AUC0-24), area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC0-last), and area under the concentration-time curve from time zero extrapolated to infinity (AUC∞) will be assessed.
Pharmacokinetic Parameter Apparent Oral Clearance (CL/F) of JZP441
Time frame: Pre-dose and multiple post-dose timepoints, up to Day 28
Pharmacokinetic Parameter Apparent Volume of Distribution (Vz/F) of JZP441
Time frame: Pre-dose and multiple post-dose timepoints, up to Day 28
Pharmacokinetic Parameter Accumulation Ratio of JZP441
Time frame: Pre-dose and multiple post-dose timepoints, up to Day 28
Accumulation ratio (Cmax) and accumulation ratio (AUC) will be assessed.
Dose Proportionality of JZP441 for Maximum Concentration (Cmax)
Time frame: Pre-dose and multiple post-dose timepoints, up to Day 28
Dose proportionality of maximum concentration (Cmax), maximum observed plasma concentration post first dose but before second dose during the 24-hour dosing interval (Cmax1), and maximum observed plasma concentration post second dose during the 24-hour dosing interval (Cmax2) will be assessed.
Dose Proportionality of JZP441 for Area Under the Concentration-Time Curve (AUC)
Time frame: Pre-dose and multiple post-dose timepoints, up to Day 28
Dose proportionality of area under the concentration-time curve from 0 to 24 hours (AUC[0-24]) will be assessed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JZP441 in people with Healthy Participants, run by Jazz Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (time frame: Day 1 up until 38 days after last dose of study drug, up to approximately 2 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.