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JZP047

Phase 1

Healthy Participants | Small molecule | Other |Jazz Pharmaceuticals plc|Last Updated: Apr 20, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment86

FDA Designations

No designations recorded

Clinical trial landscape

JZP047 · 1 trial · 1 indication

Phase 1 1
NCT07377539A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy ParticipantsHealthy Participants
RECRUITING86 Analytics
PHASE1RECRUITING
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy Participants
Healthy Participants
NCT0737753986
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Study Endpoints

Primary Endpoints

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

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.

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)
Up to 90 days

Secondary Endpoints

Dose Proportionality of JZP047 Cmax (Part A)
Up to 90 days
Dose Proportionality of JZP047 AUC0-last and AUC∞
Up to 90 days
The Effect of Food On The Single Dose PK of JZP047 Cmax
Up to 90 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: JZP047EXPERIMENTALHealthy participants who are randomized to JZP047.
Part A: PlaceboPLACEBO_COMPARATORHealthy participants who are randomized to placebo.
Part B: JZP047EXPERIMENTALHealthy participants who will receive JZP047.

Interventions

NameTypeDescription
JZP047DRUGSingle dose
PlaceboOTHERSingle dose
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 inte...

Countries:United States
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Frequently asked questions about JZP047

What is JZP047?

JZP047 is an investigational small molecule being developed by Jazz Pharmaceuticals plc. It is currently in Phase 1 clinical development for use in healthy participants. The drug is being studied to evaluate its safety, tolerability, pharmacokinetics, and food effect.

What does JZP047 target?

JZP047 is a small molecule, but its specific molecular target has not been disclosed. The drug is currently in Phase 1 trials focused on healthy participants to assess its safety, tolerability, and pharmacokinetic profile.

Who makes JZP047?

JZP047 is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker JAZZ. The company is conducting a Phase 1 clinical trial to investigate the drug's safety and tolerability in healthy participants.

What phase is JZP047 in?

JZP047 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting healthy participants to study the drug's safety, tolerability, pharmacokinetics, and food effect.

What clinical trials is JZP047 in?

JZP047 is being studied in a single Phase 1 clinical trial, NCT07377539, titled 'A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy Participants.' This randomized, double-blind, placebo-controlled trial is recruiting 86 participants in the United States.

Is JZP047 FDA approved?

JZP047 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The ongoing trial is designed to evaluate the safety, tolerability, and pharmacokinetics of JZP047 in healthy participants, and it has not yet progressed to later-stage trials or regulatory submission.