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

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.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: Fulvestrant for Injectable Suspension; Drug: Faslodex (Reference)

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.

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Network, LLC
  • Florida
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research, LLC
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami, LLC
    • Miami, Florida, United States, 33147
      • Advanced Pharma CR, LLC
    • Miami, Florida, United States, 33126
      • Quotient Sciences
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Clinical Research Consortium
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • New Horizon Clinical Research
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • New Orleans Center for Clinical Research
  • Texas
    • Austin, Texas, United States, 78705
      • Optimal Research, LLC
    • San Antonio, Texas, United States, 78217
      • Worldwide Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Body Mass Index (BMI) of 18 kg/m2 to 32 kg/m2
• Body weight of at least 50 kg at screening
• Good health as determined by evaluations
• Negative serum pregnancy test
• Subjects who are naturally postmenopausal for at least 12 consecutive months with a follicle-stimulating hormone level at Screening of ≥40 mIU/mL
• Subjects who are peri-menopausal and experiencing at least one of specified symptoms of menopause (eg, hot flashes, mood swings, night sweats, and others)
• Negative urine test for drugs of abuse
• Negative urine test for HIV antibody, HBsAG, and HCV at Screening
• Women of child-bearing potential must agree to consistently practice contraception throughout the duration of the study and continue to do so for 1 year after receiving study drug by one of the following methods: abstinence, condom, diaphragm or cervical cap with spermicide, intrauterine device or male partner had previously undergone a vasectomy as declared in medical history

Exclusion Criteria:

• Recent history (6 months) or current evidence of any clinically significant (uncontrolled) disorder including hepatic, renal, cardiovascular, psychological, pulmonary, metabolic, endocrine, neurologic, infectious, gastrointestinal, hematologic or oncologic disease, or other medical conditions that may interfere with the subject completing the study
• Lab test results outside the normal range at Screening or Day 1 considered clinically significant by the Investigator
• Use of hormonal replacement therapy within 6 months prior to randomization an/or current use of oral contraceptive pill or patch as contraceptive method throughout the study
• Concomitant medication that can affect bleeding
• Recent history (6 months) or presence of an abnormal ECG that, in the opinion of the Investigator, is clinically significant
• Subjects with QTcF interval duration >470 milliseconds
• History of alcoholism or drug addiction within 1 year prior to Day 1
• History of allergy or a known sensitivity to product components of fulvestrant Test and Reference formulations
• Creatinine clearance <60 mL/minute based on the Cockcroft-Gault equation
• Blood donation of 500 mL or more or a significant loss of blood within 56 days prior to Day 1
• Previous exposure to fulvestrant
• Familial relationship with another study participant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fulvestrant for Injectable Suspension; Fulvestrant for Injectable Suspension (500 mg/vial)	Drug: Fulvestrant for Injectable Suspension; Test drug is administered as a single 5mL intramuscular injection in the right or left dorsogluteal muscle area
Active Comparator: Faslodex (R); Faslodex (250 mg/mL)	Drug: Faslodex (Reference); Reference drug is administered as two 5mL intramuscular injections, one in each of the right and left dorsogluteal muscle areas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic parameters	Area under the concentration-time curve(AUC)	Day 0 through Day 140

Collaborators and Investigators

• Sponsor: Eagle Pharmaceuticals, Inc.
• Investigators: Study Director: Adrian J Hepner, MD, PhD, Eagle Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Actual): July 12, 2018
• Study Completion (Actual): July 12, 2018

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (Actual): October 27, 2017

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Estrogen Antagonists; Estrogen Receptor Antagonists; Fulvestrant
• Other Study ID Numbers: EGL-5835-C-1701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No