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

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Jazz Pharmaceuticals
Study ID
NCT07377539
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • JZP047 — DRUG
    Single dose
  • Placebo — OTHER
    Single dose

Study Details

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.

Key Dates

Start date
Feb 3, 2026
Status verified
Apr 2026
Primary completion
Jul 5, 2026
Completion
Jul 5, 2026

Study Design

Enrollment
86 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Number of Participants Reporting Treatment-emergent Adverse Events (Part A) [ Time Frame: Baseline up to Day 90 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion, Inc.LincolnNebraska68502-

Find similar trials in Lincoln, NE

By research site
Celerion, Inc.· Lincoln, NE

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