CClinicalTrials.gg
RecruitingNCT07377539Updated Apr 20, 2026

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy Participants

A Phase 1 interventional study of JZP047 and Placebo in Healthy Participants, sponsored by Jazz Pharmaceuticals. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by Jazz Pharmaceuticals · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Feb 2026; still recruiting 8 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the detailed description

The study will consist of 2 parts: a single-dose ascending part (Part A [SAD] and a single dose under fed conditions part (Part B [Fed PK]).

The study design for Part A will be double-blind, sponsor-unblinded, randomized, and placebo-controlled. Part B, the single dose under fed conditions, will have an open-label study design.

Part A will characterize safety, tolerability, and PK following single doses of JZP047 and matching placebo in healthy male and female participants. Part B will explore the effect of food on a single dose of JZP047 in healthy male and female participants in the fed state.

02

Conditions studied

  • Healthy Participants

Keywords

  • Healthy Participants
  • JZP047
03

In context

Lead sponsor

Jazz Pharmaceuticals is the lead sponsor of 167 studies on the registry; 20 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
86 participants (estimated)

Study arms

  • Experimental
    Part A: JZP047

    Healthy participants who are randomized to JZP047.

    Drug: JZP047

  • Placebo comparator
    Part A: Placebo

    Healthy participants who are randomized to placebo.

    Other: Placebo

  • Experimental
    Part B: JZP047

    Healthy participants who will receive JZP047.

    Drug: JZP047

Interventions

  • DrugJZP047

    Single dose

  • OtherPlacebo

    Single dose

06

What researchers measure

Primary outcomes

  1. Number of Participants Reporting Treatment-emergent Adverse Events (Part A)

    Time frame: Baseline up to Day 90

  2. Number of Participants Reporting Treatment-emergent Adverse Events (Part B)

    Time frame: Baseline up to Day 90

  3. Number of Participants Who Discontinued The Study (Part A)

    Time frame: Baseline up to Day 90

  4. Number of Participants Who Discontinued The Study (Part B)

    Time frame: Baseline up to Day 90

  5. Pharmacokinetic Parameter Maximum Concentration (Part A)

    Time frame: Up to 90 days

  6. Pharmacokinetic Parameter Time to Maximum Concentration and Time Before the Start of Absorption (Part A)

    Time frame: Up to 90 days

  7. Pharmacokinetic Parameter Terminal Elimination Half-life (Part A)

    Time frame: Up to 90 days

  8. Pharmacokinetic Parameter Terminal Elimination Rate Constant (Part A)

    Time frame: Up to 90 days

  9. Pharmacokinetic Parameter Volume of Distribution During Terminal Phase (Part A)

    Time frame: Up to 90 days

  10. Pharmacokinetic Parameter Oral Clearance (Part A)

    Time frame: Up to 90 days

  11. Pharmacokinetic Parameter Area Under the Concentration-Time Curve (Part A)

    Area under the concentration-time curve from time 0 to 24 (AUC0-24), 0 to last measurable concentration (AUClast), and 0 to infinity (AUC∞) will be assessed.

    Time frame: Up to 90 days

  12. 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

Secondary outcomes

  1. Dose Proportionality of JZP047 Cmax (Part A)

    Time frame: Up to 90 days

  2. Dose Proportionality of JZP047 AUC0-last and AUC∞

    Time frame: Up to 90 days

  3. The Effect of Food On The Single Dose PK of JZP047 Cmax

    Time frame: Up to 90 days

  4. The Effect of Food On The Single Dose PK of JZP047 AUC0-last and AUC∞

    Time frame: Up to 90 days

07

Study locations

1 of 1 sites recruiting
  • Celerion, Inc.
    Lincoln, Nebraska 68502, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07377539
Lead sponsor
Jazz Pharmaceuticals
Collaborators
Jazz Pharmaceuticals Ireland Limited
Responsible party
Sponsor
First posted
Jan 30, 2026
Start date
Feb 3, 2026
Primary completion
Jul 5, 2026 (estimated)
Completion
Jul 5, 2026 (estimated)
Last update
Apr 20, 2026

Study contacts

Clinical Trial Disclosure & Transparency
Contact
ClinicalTrialDisclosure@JazzPharma.com
215-832-3750

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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