“A Study to Evaluate the Rate of Nausea in Healthy Premenopausal Female Subjects Treated With a Single Dose of Bremelanotide Alone or With Zofran”
This is a Phase 1, randomized study to evaluate the rate of nausea in healthy premenopausal study participants following a single dose of BMT with or without a single 8 mg po dose of Zofran given 30 minutes before BMT dosing. The study consists of a 21-day screening period for subject eligibility followed by a 1-day double-blind period in which all subjects receive a single open-label dose of 1.75 mg SC BMT after receiving a single blinded dose of Zofran (ondansetron) 8 mg or placebo. Approximately 228 subjects will be enrolled at up to two study sites in the United States. Safety and tolerability of BMT administration will be summarized and assessed.
Drug - Bremelanotide
Sterile aqueous solution for injection, provided as an autoinjector pen
Drug - Zofran
8 mg tablet (over-encapsulation in a capsule)
Drug - Placebo
A Phase 1, Randomized Study to Evaluate the Rate of Nausea in Healthy Premenopausal Female Subjects Treated With a Single Dose of Bremelanotide Alone or With Zofran