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

Eagle Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Pharmacokinetics

Treatments

Drug: Fulvestrant for Injectable Suspension

Drug: Faslodex (Reference)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03324061

EGL-5835-C-1701

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 patients

Sex

Female

Ages

40 to 75 years old

Volunteers

Accepts Healthy Volunteers

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