Actively Recruiting
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy Participants
Led by Jazz Pharmaceuticals · Updated on 2026-04-20
86
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
J
Jazz Pharmaceuticals
Lead Sponsor
J
Jazz Pharmaceuticals Ireland Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase 1, double-blind, sponsor-unblinded, randomized, placebo-controlled study designed to characterize the safety, tolerability, and PK of JZP047 in healthy participants following single-ascending doses of study intervention. Additionally, the effect of food on PK following a single dose of JZP047 will be assessed through comparison of PK between the fed and fasted states.
CONDITIONS
Official Title
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy participants aged 18 to 55 years willing and able to comply with study requirements
- Male participants must agree to refrain from donating sperm during the study and for 120 days after last dose
- Male participants must use a male condom with a female partner and an additional highly effective contraceptive method when having sexual intercourse with women of childbearing potential
- Male participants must agree to use a male condom when engaging in any activity allowing passage of ejaculate to another person
- Female participants must be women of nonchildbearing potential
- Female participants must have a negative pregnancy test before receiving study intervention
You will not qualify if you...
- History or presence of significant medical illness or conditions affecting drug absorption, distribution, metabolism, or excretion
- History or presence of significant allergies other than seasonal allergies not requiring treatment during the study
- History or diagnosis within 5 years of alcohol or substance abuse, known drug dependence, or treatment for related disorders
- Current diagnosis or treatment for depression, or major depressive episode within past 5 years
- History of suicide attempt, current suicidal risk or active suicidal thoughts
- Any condition posing risk to participant as determined by investigator
- Poor peripheral venous access or history of fainting during blood draws
- Use or planned use of prescription or nonprescription drugs, including vitamins and supplements, within 14 days or 5 half-lives before check-in and through study conduct
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Celerion, Inc.
Lincoln, Nebraska, United States, 68502
Actively Recruiting
Research Team
C
Clinical Trial Disclosure & Transparency
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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