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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Drug: Fulvestrant for Injectable Suspension
* Drug: Faslodex (Reference)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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