NCT03973047

Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: AMAG Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Nausea

Interventions

Type	Name	Description
DRUG	Bremelanotide	Sterile aqueous solution for injection, provided as an autoinjector pen
DRUG	Zofran	8 mg tablet (over-encapsulation in a capsule)
DRUG	Placebo	capsule

Timeline

• Start date: 2019-06-17
• Primary completion: 2019-07-19
• Completion: 2019-07-20
• First posted: 2019-06-04
• Last updated: 2022-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study