Study to Evaluate the Safety, Tolerability, and PK of Fulvestrant After IM Administration
NCT ID: NCT03324061
Last Updated: 2021-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
600 participants
INTERVENTIONAL
2017-11-30
2018-07-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Fulvestrant for Injectable Suspension
Fulvestrant for Injectable Suspension (500 mg/vial)
Fulvestrant for Injectable Suspension
Test drug is administered as a single 5mL intramuscular injection in the right or left dorsogluteal muscle area
Faslodex (R)
Faslodex (250 mg/mL)
Faslodex (Reference)
Reference drug is administered as two 5mL intramuscular injections, one in each of the right and left dorsogluteal muscle areas
Interventions
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Fulvestrant for Injectable Suspension
Test drug is administered as a single 5mL intramuscular injection in the right or left dorsogluteal muscle area
Faslodex (Reference)
Reference drug is administered as two 5mL intramuscular injections, one in each of the right and left dorsogluteal muscle areas
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
75 Years
FEMALE
Yes
Sponsors
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Eagle Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Adrian J Hepner, MD, PhD
Role: STUDY_DIRECTOR
Eagle Pharmaceuticals, Inc.
Locations
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Collaborative Neuroscience Network, LLC
Long Beach, California, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States
Quotient Sciences
Miami, Florida, United States
Advanced Pharma CR, LLC
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Clinical Research Consortium
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
New Horizon Clinical Research
Cincinnati, Ohio, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
Optimal Research, LLC
Austin, Texas, United States
Worldwide Clinical Trials
San Antonio, Texas, United States
Countries
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Other Identifiers
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EGL-5835-C-1701
Identifier Type: -
Identifier Source: org_study_id
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