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NOT YET RECRUITING
NCT07377539
PHASE1

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

Sponsor: Jazz Pharmaceuticals

View on ClinicalTrials.gov

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.

Official title: A Double-Blind, Sponsor-Unblinded, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of Single-Ascending Doses of JZP047 and an Open-Label Food Effect Study of JZP047 in Healthy Male and Female Participants

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

86

Start Date

2026-02-03

Completion Date

2026-07-05

Last Updated

2026-01-30

Healthy Volunteers

Yes

Interventions

DRUG

JZP047

Single dose

OTHER

Placebo

Single dose