NCT03324061

Study to Evaluate the Safety, Tolerability, and PK of Fulvestrant After IM Administration

A Phase 1, Randomized, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Fulvestrant (Test vs. Reference) Following Intramuscular Administration to the Gluteal Muscle in Healthy Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Eagle Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Clinical study designed to assess the plasma pharmacokinetic profile and tolerability of Fulvestrant for Injectable Suspension after a single IM dose of Fulvestrant for Injectable Suspension compared to the reference product, Faslodex in healthy female subjects.

Detailed description

This is a Phase 1, open-label, parallel group study in healthy female subjects. The study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of a single dose of Fulvestrant for Injectable Suspension vs. the reference drug, Faslodex, administered in the gluteal muscle.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Fulvestrant for Injectable Suspension	Test drug is administered as a single 5mL intramuscular injection in the right or left dorsogluteal muscle area
DRUG	Faslodex (Reference)	Reference drug is administered as two 5mL intramuscular injections, one in each of the right and left dorsogluteal muscle areas

Timeline

• Start date: 2017-11-30
• Primary completion: 2018-07-12
• Completion: 2018-07-12
• First posted: 2017-10-27
• Last updated: 2021-06-03

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study