Clinical trial NCT03324061: Study to Evaluate the Safety, Tolerability, and PK of Fulvestrant After IM Administration
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Eagle Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-27
Enrollment: 600
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetic parameters
timeFrame: Day 0 through Day 140
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, LLC
state: Florida
city: Miami
country: United States
facility: Quotient Sciences
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Las Vegas
country: United States
facility: Clinical Research Consortium
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Cincinnati
country: United States
facility: New Horizon Clinical Research
state: Ohio
city: Knoxville
country: United States
facility: New Orleans Center for Clinical Research
state: Tennessee
city: Austin
country: United States
facility: Optimal Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Worldwide Clinical Trials
state: Texas
Study officials:
affiliation: Eagle Pharmaceuticals, Inc.
name: Adrian J Hepner, MD, PhD
role: STUDY_DIRECTOR
References: