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.
Healthy participants 18 to 55 years of age, willing and able to comply with study requirements.
Refrain from donating sperm.
Use a male condom with female partner and use of an additional highly effective contraceptive method with a failure rate of < 1% per year and should also be advised of the benefit of a female partner using a highly effective method of contraception, as a condom may break or leak, when having sexual intercourse with a woman of childbearing potential (WOCBP) who is currently not pregnant.
Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person.
None
Sequential
JZP047
DrugSingle dose
Placebo
Other interventionSingle dose
Number of Participants Reporting Treatment-emergent Adverse Events (Part A)
Number of Participants Reporting Treatment-emergent Adverse Events (Part B)
Number of Participants Who Discontinued The Study (Part A)
Number of Participants Who Discontinued The Study (Part B)
Dose Proportionality of JZP047 Cmax (Part A)
Dose Proportionality of JZP047 AUC0-last and AUC∞
The Effect of Food On The Single Dose PK of JZP047 Cmax
The Effect of Food On The Single Dose PK of JZP047 AUC0-last and AUC∞
Click on the lead sponsor to view all of their trials.
Jazz Pharmaceuticals
Lead sponsor
Jazz Pharmaceuticals Ireland Limited
Collaborator
