Recruiting
Phase 1

JZP047

Sponsor:

Jazz Pharmaceuticals

Code:

NCT07377539

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

JZP047

Placebo

Study Details

Brief summary:

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

Healthy Participants

Study ID

NCT07377539

Start date

Feb 3, 2026

Status verified date

Apr, 2026

Completion date

Jul 5, 2026

Anticipated

Primary completion date

Jul 5, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

86 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: JZP047

Healthy participants who are randomized to JZP047.

placebo comparator: Part A: Placebo

Healthy participants who are randomized to placebo.

experimental: Part B: JZP047

Healthy participants who will receive JZP047.

Interventions

JZP047

Single dose

Placebo

Single dose

Primary outcome measure

  • Number of Participants Reporting Treatment-emergent Adverse Events (Part A) [ Time Frame: Baseline up to Day 90 ]
  • Number of Participants Reporting Treatment-emergent Adverse Events (Part B) [ Time Frame: Baseline up to Day 90 ]
  • Number of Participants Who Discontinued The Study (Part A) [ Time Frame: Baseline up to Day 90 ]
  • Number of Participants Who Discontinued The Study (Part B) [ Time Frame: Baseline up to Day 90 ]
  • Pharmacokinetic Parameter Maximum Concentration (Part A) [ Time Frame: Up to 90 days ]
  • Pharmacokinetic Parameter Time to Maximum Concentration and Time Before the Start of Absorption (Part A) [ Time Frame: Up to 90 days ]
  • Pharmacokinetic Parameter Terminal Elimination Half-life (Part A) [ Time Frame: Up to 90 days ]
  • Pharmacokinetic Parameter Terminal Elimination Rate Constant (Part A) [ Time Frame: Up to 90 days ]
  • Pharmacokinetic Parameter Volume of Distribution During Terminal Phase (Part A) [ Time Frame: Up to 90 days ]
  • Pharmacokinetic Parameter Oral Clearance (Part A) [ Time Frame: Up to 90 days ]
  • Pharmacokinetic Parameter Area Under the Concentration-Time Curve (Part A) [ Time Frame: Up to 90 days ]
  • Pharmacokinetic Parameter Percentage of The Area Under the Concentration-Time Curve From Time Infinity Due to Extrapolation From The Last Quantifiable Concentration to Time Infinity (Part A) [ Time Frame: Up to 90 days ]

Central Contacts and Locations

Central contacts

Clinical Trial Disclosure & Transparency

215-832-3750ClinicalTrialDisclosure@JazzPharma.com

Locations

Celerion, Inc.

Recruiting

Lincoln, Nebraska, United States, 68502

More Information

Sponsor

Jazz Pharmaceuticals

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Keywords

  • Healthy Participants
  • JZP047

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jazz Pharmaceuticals on 2026-04-20.