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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03324061
• Other study ID #: EGL-5835-C-1701
• Status: Completed
• Phase: Phase 1
• Start date: November 30, 2017
• Est. completion date: July 12, 2018

Study information

• Verified date: June 2021
• Source: Eagle Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: July 12, 2018
• Est. primary completion date: July 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• Fulvestrant for Injectable Suspension
Test drug is administered as a single 5mL intramuscular injection in the right or left dorsogluteal muscle area
• Faslodex (Reference)
Reference drug is administered as two 5mL intramuscular injections, one in each of the right and left dorsogluteal muscle areas

Locations

Country	Name	City	State
United States	Optimal Research, LLC	Austin	Texas
United States	Hassman Research Institute	Berlin	New Jersey
United States	New Horizon Clinical Research	Cincinnati	Ohio
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	New Orleans Center for Clinical Research	Knoxville	Tennessee
United States	Clinical Research Consortium	Las Vegas	Nevada
United States	Collaborative Neuroscience Network, LLC	Long Beach	California
United States	Advanced Pharma CR, LLC	Miami	Florida
United States	Clinical Pharmacology of Miami, LLC	Miami	Florida
United States	Quotient Sciences	Miami	Florida
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Worldwide Clinical Trials	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eagle Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters	Area under the concentration-time curve(AUC)	Day 0 through Day 140