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
1 other identifier
interventional
600
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2017
Shorter than P25 for phase_1
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2017
CompletedFirst Posted
Study publicly available on registry
October 27, 2017
CompletedStudy Start
First participant enrolled
November 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2018
CompletedJune 3, 2021
June 1, 2021
7 months
October 24, 2017
June 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic parameters
Area under the concentration-time curve(AUC)
Day 0 through Day 140
Study Arms (2)
Fulvestrant for Injectable Suspension
EXPERIMENTALFulvestrant for Injectable Suspension (500 mg/vial)
Faslodex (R)
ACTIVE COMPARATORFaslodex (250 mg/mL)
Interventions
Test drug is administered as a single 5mL intramuscular injection in the right or left dorsogluteal muscle area
Reference drug is administered as two 5mL intramuscular injections, one in each of the right and left dorsogluteal muscle areas
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014, United States
Quotient Sciences
Miami, Florida, 33126, United States
Advanced Pharma CR, LLC
Miami, Florida, 33147, United States
Orlando Clinical Research Center
Orlando, Florida, 32809, United States
Clinical Research Consortium
Las Vegas, Nevada, 89119, United States
Hassman Research Institute
Berlin, New Jersey, 08009, United States
New Horizon Clinical Research
Cincinnati, Ohio, 45242, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920, United States
Optimal Research, LLC
Austin, Texas, 78705, United States
Worldwide Clinical Trials
San Antonio, Texas, 78217, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Adrian J Hepner, MD, PhD
Eagle Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2017
First Posted
October 27, 2017
Study Start
November 30, 2017
Primary Completion
July 12, 2018
Study Completion
July 12, 2018
Last Updated
June 3, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share