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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
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.
The study will consist of 2 parts: a single-dose ascending part (Part A \[SAD\] and a single dose under fed conditions part (Part B \[Fed PK\]). The study design for Part A will be double-blind, sponsor-unblinded, randomized, and placebo-controlled. Part B, the single dose under fed conditions, will have an open-label study design. Part A will characterize safety, tolerability, and PK following single doses of JZP047 and matching placebo in healthy male and female participants. Part B will explore the effect of food on a single dose of JZP047 in healthy male and female participants in the fed state.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
Yes
Start Date
February 3, 2026
Primary Completion Date
July 5, 2026
Completion Date
July 5, 2026
Last Updated
January 30, 2026
86
ESTIMATED participants
JZP047
DRUG
Placebo
OTHER
Lead Sponsor
Jazz Pharmaceuticals
Collaborators
NCT07310901
NCT06342713
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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