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
Phase of Trial: Phase I
Latest Information Update: 26 Feb 2018
At a glance
- Drugs Fulvestrant (Primary)
- Indications Breast cancer
- Focus Pharmacokinetics
- Sponsors Eagle Pharmaceuticals
- 26 Feb 2018 According to an Eagle Pharmaceuticals media release, randomization has now been completed ahead of schedule with 600 subjects.
- 07 Dec 2017 Status changed from not yet recruiting to recruiting, according to an Eagle Pharmaceuticals media release.
- 07 Dec 2017 According to an Eagle Pharmaceuticals media release, dosing in the first cohort in this trial was started on 30 Nov 2017. The Company anticipates dosing its last subject during the first half of 2018, with study completion within twelve months, and an expected NDA filing in the fourth quarter of 2018.