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
Jazz Pharmaceuticals
Lead sponsor
Jazz Pharmaceuticals Ireland Limited
Collaborator