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

• ClinicalTrials.gov Identifier: NCT03324061
• Recruitment Status: Unknown
• First Posted: October 27, 2017
• Last Update Posted: June 21, 2018
• Sponsor: Eagle Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Eagle Pharmaceuticals, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pharmacokinetics	Drug: Fulvestrant for Injectable Suspension; Drug: Faslodex (Reference)	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: November 30, 2017
• Estimated Primary Completion Date: August 2018
• Estimated Study Completion Date: September 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Pharmacokinetic parameters [ Time Frame: Day 0 through Day 140 ]
   Area under the concentration-time curve(AUC)

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, California

Collaborative Neuroscience Network, LLC

Long Beach, California, United States, 90806

United States, Florida

Avail Clinical Research, LLC

DeLand, Florida, United States, 32720

Clinical Pharmacology of Miami, LLC

Miami, Florida, United States, 33014

Quotient Sciences

Miami, Florida, United States, 33126

Advanced Pharma CR, LLC

Miami, Florida, United States, 33147

Orlando Clinical Research Center

Orlando, Florida, United States, 32809

United States, Nevada

Clinical Research Consortium

Las Vegas, Nevada, United States, 89119

United States, New Jersey

Hassman Research Institute

Berlin, New Jersey, United States, 08009

United States, Ohio

New Horizon Clinical Research

Cincinnati, Ohio, United States, 45242

United States, Tennessee

New Orleans Center for Clinical Research

Knoxville, Tennessee, United States, 37920

United States, Texas

Optimal Research, LLC

Austin, Texas, United States, 78705

Worldwide Clinical Trials

San Antonio, Texas, United States, 78217

Sponsors and Collaborators

Eagle Pharmaceuticals, Inc.

Investigators

• Study Director: Adrian J Hepner, MD, PhD; Eagle Pharmaceuticals, Inc.

More Information

• Responsible Party: Eagle Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT03324061
• Other Study ID Numbers: EGL-5835-C-1701
• First Posted: October 27, 2017
• Last Update Posted: June 21, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Fulvestrant; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Estrogen Receptor Antagonists; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs