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
Jazz Pharmaceuticals
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.
Description
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 fe…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
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 intervention period and for at least 120 days after the last dose of study intervention: * Refrain from donating sperm. * Use contraception/barrier as follows: * Use a male condom with female partner and use of an additional highly effective contraceptive method with a failure rate of \< 1%…
Interventions
- DrugJZP047
Single dose
- OtherPlacebo
Single dose
Location
- Celerion, Inc.Lincoln, Nebraska