Safety, tolerability, and food effects of JZP047 in healthy adults
A Double-Blind, Sponsor-Unblinded, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of Single-Ascending Doses of JZP047 and an Open-Label Food Effect Study of JZP047 in Healthy Male and Female Participants
This trial will test how a single dose of JZP047 is tolerated and processed in healthy adults and whether taking it with food changes its levels.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Jazz Pharmaceuticals Industry-sponsored |
| Locations | 1 site (Lincoln, Nebraska) |
| Trial ID | NCT07377539 on ClinicalTrials.gov |
What this trial studies
This Phase 1 study enrolls healthy men and women aged 18–55 to characterize safety, tolerability, and pharmacokinetics after single ascending doses of JZP047. Part A is randomized, double-blind (sponsor-unblinded) and placebo-controlled to evaluate safety and PK across dose levels. Part B is an open-label fed-state PK comparison to see how a single dose behaves with food versus fasting. Intensive blood sampling and safety monitoring will be used to define PK parameters and adverse event profiles.
Who should consider this trial
Good fit: Healthy adults 18 to 55 who can comply with study procedures, attend site visits, and follow contraception and sperm-donation restrictions as specified are eligible.
Not a fit: People seeking therapeutic benefit for a medical condition, pregnant or breastfeeding individuals, and those who do not meet healthy volunteer criteria are unlikely to receive clinical benefit from this Phase 1 trial.
Why it matters
Potential benefit: If successful, the results could identify safe dose ranges and show whether food affects JZP047 levels, which would guide dosing in later studies.
How similar studies have performed: Single-ascending-dose and fed/fasted PK studies are a standard, routinely successful approach for early safety and PK characterization, though JZP047 itself is a new compound.
Eligibility criteria
Show full inclusion / exclusion criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
1. Healthy participants 18 to 55 years of age, willing and able to comply with study requirements.
2. Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 120 days after the last dose of study intervention:
* Refrain from donating sperm.
* Use contraception/barrier as follows:
* Use a male condom with female partner and use of an additional highly effective contraceptive method with a failure rate of \< 1% per year and should also be advised of the benefit of a female partner using a highly effective method of contraception, as a condom may break or leak, when having sexual intercourse with a woman of childbearing potential (WOCBP) who is currently not pregnant.
* Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person.
3. Female participants are eligible to participate if:
* She is a woman of nonchildbearing potential (WONCBP).
* Pregnancy testing will be performed prior to administration of study intervention to confirm female participants are not pregnant.
Participants are excluded from the study if any of the following criteria apply:
1. History of or presence of clinically significant medical illness or disorder or have a medical issue that may interfere with absorption, distribution, metabolism, or excretion of drugs..
2. History or presence of clinically significant allergy (other than seasonal allergies that do not require treatment during the study) or clinically significant allergy to adhesive bandages, adhesive dressing, ECG patches, or medical tape.
3. History (within 5 past years) or presence of a diagnosis of alcohol abuse, a substance abuse disorder, known drug dependence, or seeking of treatment for an alcohol- or substance abuse-related disorder.
4. Current diagnosis of or receiving treatment for depression; past (within 5 years) clinically significant major depressive episode.
5. History of suicide attempt, current suicidal risk as determined from history, or presence of active suicidal ideation.
6. Presence of any other condition that will cause a risk to participants if they participate in the study as determined by the investigator.
7. Poor peripheral venous access or history of fainting (or passing out) during blood draws.
8. Use or intent to use any prescription medications or nonprescription drugs (including vitamins, recreational drugs, and dietary or herbal supplements) within 14 days or for 5 half-lives, whichever is longer prior to Check-in and throughout the conduct of the study.
Where this trial is running
Lincoln, Nebraska
- Celerion, Inc. — Lincoln, Nebraska, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trial Disclosure & Transparency
- Email: ClinicalTrialDisclosure@JazzPharma.com
- Phone: 215-832-3750
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.