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

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: Fulvestrant for Injectable Suspension; Drug: Faslodex (Reference)

• Registration Number: NCT03324061
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2017-10-26
• Study First Posted: 2017-10-27
• Study Start: 2017-11-30
• Primary Completion: 2018-07-12
• Study Completion: 2018-07-12
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-02
• Last Update Posted: 2021-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 600

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fulvestrant for Injectable Suspension	Fulvestrant for Injectable Suspension	Fulvestrant for Injectable Suspension (500 mg/vial)
Faslodex (R)	Faslodex (Reference)	Faslodex (250 mg/mL)

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters	Day 0 through Day 140	Area under the concentration-time curve(AUC)

Trial Locations

Locations (12)

New Orleans Center for Clinical Research; 🇺🇸 Knoxville, Tennessee, United States

Hassman Research Institute; 🇺🇸 Berlin, New Jersey, United States

Worldwide Clinical Trials; 🇺🇸 San Antonio, Texas, United States

New Horizon Clinical Research; 🇺🇸 Cincinnati, Ohio, United States

Collaborative Neuroscience Network, LLC; 🇺🇸 Long Beach, California, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Clinical Pharmacology of Miami, LLC; 🇺🇸 Miami, Florida, United States

Avail Clinical Research, LLC; 🇺🇸 DeLand, Florida, United States

Advanced Pharma CR, LLC; 🇺🇸 Miami, Florida, United States

Quotient Sciences; 🇺🇸 Miami, Florida, United States

Optimal Research, LLC; 🇺🇸 Austin, Texas, United States

Clinical Research Consortium; 🇺🇸 Las Vegas, Nevada, United States