A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy Participants
NCT07377539 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86
Last updated 2026-04-20
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
Interventions
- DRUG
-
JZP047
Single dose
- OTHER
-
Placebo
Single dose
Sponsors & Collaborators
-
Jazz Pharmaceuticals Ireland Limited
collaborator INDUSTRY - lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-02-03
- Primary Completion
- 2026-07-05
- Completion
- 2026-07-05
- FDA Drug
- Yes
Countries
- United States
Study Locations
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