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JZP047

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment86
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07377539A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy ParticipantsPHASE1 RECRUITING 86 — — Feb 3, 2026Jul 5, 2026Apr 20, 20261 United States
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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 — 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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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07377539Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07377539studyFirstPostDate: changed