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

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ClinicalTrials.gov Identifier: NCT03324061
Recruitment Status : Completed
First Posted : October 27, 2017
Last Update Posted : June 3, 2021
Information provided by (Responsible Party):
Eagle Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Pharmacokinetics Drug: Fulvestrant for Injectable Suspension Drug: Faslodex (Reference) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : November 30, 2017
Actual Primary Completion Date : July 12, 2018
Actual Study Completion Date : July 12, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Fulvestrant

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

Primary Outcome Measures :
  1. Pharmacokinetic parameters [ Time Frame: Day 0 through Day 140 ]
    Area under the concentration-time curve(AUC)

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324061

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United States, California
Collaborative Neuroscience Network, LLC
Long Beach, California, United States, 90806
United States, Florida
Avail Clinical Research, LLC
DeLand, Florida, United States, 32720
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States, 33014
Quotient Sciences
Miami, Florida, United States, 33126
Advanced Pharma CR, LLC
Miami, Florida, United States, 33147
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Nevada
Clinical Research Consortium
Las Vegas, Nevada, United States, 89119
United States, New Jersey
Hassman Research Institute
Berlin, New Jersey, United States, 08009
United States, Ohio
New Horizon Clinical Research
Cincinnati, Ohio, United States, 45242
United States, Tennessee
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States, 37920
United States, Texas
Optimal Research, LLC
Austin, Texas, United States, 78705
Worldwide Clinical Trials
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Eagle Pharmaceuticals, Inc.
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Study Director: Adrian J Hepner, MD, PhD Eagle Pharmaceuticals, Inc.
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Responsible Party: Eagle Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03324061    
Other Study ID Numbers: EGL-5835-C-1701
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: June 3, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs