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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
86
Celerion, Inc.
Lincoln, Nebraska, United States
RECRUITINGNumber of Participants Reporting Treatment-emergent Adverse Events (Part A)
Time frame: Baseline up to Day 90
Number of Participants Reporting Treatment-emergent Adverse Events (Part B)
Time frame: Baseline up to Day 90
Number of Participants Who Discontinued The Study (Part A)
Time frame: Baseline up to Day 90
Number of Participants Who Discontinued The Study (Part B)
Time frame: Baseline up to Day 90
Pharmacokinetic Parameter Maximum Concentration (Part A)
Time frame: Up to 90 days
Pharmacokinetic Parameter Time to Maximum Concentration and Time Before the Start of Absorption (Part A)
Time frame: Up to 90 days
Pharmacokinetic Parameter Terminal Elimination Half-life (Part A)
Time frame: Up to 90 days
Pharmacokinetic Parameter Terminal Elimination Rate Constant (Part A)
Time frame: Up to 90 days
Pharmacokinetic Parameter Volume of Distribution During Terminal Phase (Part A)
Time frame: Up to 90 days
Pharmacokinetic Parameter Oral Clearance (Part A)
Time frame: Up to 90 days
Pharmacokinetic Parameter Area Under the Concentration-Time Curve (Part A)
Area under the concentration-time curve from time 0 to 24 (AUC0-24), 0 to last measurable concentration (AUClast), and 0 to infinity (AUC∞) will be assessed.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 90 days
Pharmacokinetic Parameter Percentage of The Area Under the Concentration-Time Curve From Time Infinity Due to Extrapolation From The Last Quantifiable Concentration to Time Infinity (Part A)
Time frame: Up to 90 days
Dose Proportionality of JZP047 Cmax (Part A)
Time frame: Up to 90 days
Dose Proportionality of JZP047 AUC0-last and AUC∞
Time frame: Up to 90 days
The Effect of Food On The Single Dose PK of JZP047 Cmax
Time frame: Up to 90 days
The Effect of Food On The Single Dose PK of JZP047 AUC0-last and AUC∞
Time frame: Up to 90 days