JZP047 for Healthy Participants
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called JZP047 to evaluate its safety and how the body processes it in healthy individuals. Researchers aim to understand the drug's behavior when taken with or without food. Participants will receive either JZP047 or a placebo (a harmless pill with no effect) for comparison. The trial seeks healthy individuals who can commit to the study's requirements and have no significant medical conditions or allergies that might interfere. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking any prescription or nonprescription medications, including vitamins and supplements, at least 14 days before the study starts and throughout the study.
Is there any evidence suggesting that JZP047 is likely to be safe for humans?
Research has shown that JZP047 is being tested for safety and tolerance in healthy individuals. Although specific data from earlier studies on JZP047's safety is unavailable, this trial is in an early phase. Such trials focus on the treatment's tolerance in people and typically involve a small number of participants to monitor side effects closely.
JZP047 is being developed to treat absence epilepsy. While this does not guarantee safety, it indicates researchers' interest in understanding its effects.
In early trials, researchers test different doses to determine a safe and effective amount. Participants receive close monitoring for any side effects. If JZP047 proves unsafe in these early tests, further development would likely cease.12345Why do researchers think this study treatment might be promising?
JZP047 is unique because it represents a novel approach to treatment with its distinct mechanism of action. Unlike traditional medications that might focus on symptoms, JZP047 potentially targets the underlying pathways more directly. Researchers are particularly excited about JZP047's potential to offer improved efficacy or reduced side effects compared to existing options. This could lead to a significant advancement in how we manage certain health conditions, offering new hope for better patient outcomes.
What evidence suggests that JZP047 could be effective?
Research shows that JZP047 is a new treatment undergoing safety testing in healthy individuals. In this trial, some participants will receive JZP047, while others will receive a placebo. Currently, there is limited information on its effectiveness for any specific illness because the primary goal is to assess how the body processes the drug. The study also examines how food intake might influence the drug's metabolism. Although specific results on effectiveness are not yet available, researchers are gathering preliminary data that could inform future studies. More detailed findings will emerge as research progresses.12467
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18 to 55 who do not have significant medical conditions, recent substance or alcohol abuse, major depression in the past five years, or serious allergies. Participants must agree to use effective contraception and comply with study requirements.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single-Ascending Dose (SAD)
Characterization of safety, tolerability, and pharmacokinetics following single doses of JZP047 and placebo
Food Effect Study
Exploration of the effect of food on a single dose of JZP047 in the fed state
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- JZP047
- Placebo
Trial Overview
The study tests different single doses of a new drug called JZP047 compared to a placebo in healthy people. It looks at safety, how well participants tolerate the drug, how the body processes it, and whether food affects its absorption.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Healthy participants who will receive JZP047.
Healthy participants who are randomized to JZP047.
Healthy participants who are randomized to placebo.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jazz Pharmaceuticals
Lead Sponsor
Bruce C. Cozadd
Jazz Pharmaceuticals
Chief Executive Officer since 2009
BA in Economics from Yale University, MBA from Stanford University
Dr. Austin
Jazz Pharmaceuticals
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland
Jazz Pharmaceuticals Ireland Limited
Industry Sponsor
Citations
NCT07377539 | A Study to Investigate the Safety, ...
Part B will explore the effect of food on a single dose of JZP047 in healthy male and female participants in the fed state. Official Title. A Double-Blind, ...
2.
trial.medpath.com
trial.medpath.com/clinical-trial/62c335538670e849/nct07377539-jzp047-safety-tolerability-pharmacokinetics-healthy-participantsA Study to Investigate the Safety,... | Clinical Trial - MedPath
Healthy participants who are randomized to placebo. Intervention: Placebo. Part B: JZP047. Healthy participants who will receive JZP047.
Clinical Trial on JZP047 - ICH GCP
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy Participants. April 15, 2026 updated by: ...
4.
investor.jazzpharma.com
investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-provides-update-phase-2-trialJazz Pharmaceuticals Provides Update on Phase 2 Trial of ...
The trial randomized 282 adults aged 18 to 70 diagnosed with PTSD using the criteria of the American Psychiatric Association's Diagnostic and Statistical ...
5.
trial.medpath.com
trial.medpath.com/clinical-trial/687a54ce5d3e08d9/nct07377656-bivalent-hpv-vaccine-safety-immunogenicity-infants-children-females-ghanaStrengthening HPV Immunization Through EPI Leveraged Delivery ...
This is a randomized observer-blind placebo-controlled proof-of-concept study with the aim to assess the safety and tolerability, and the immunogenicity of ...
JZP 047 - AdisInsight
JZP 047 is a therapeutic, being developed by Jazz Pharmaceuticals for the treatment of absence epilepsy. Cinical development is underway in ...
A Double-Blind, Sponsor-Unblinded, Randomized, Placebo ...
This is a Phase 1, double-blind, sponsor-unblinded, randomized, placebo-controlled study designed to characterize the safety, tolerability, and PK of JZP047 ...
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