Clincosm LogoSign in Get a demo

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

Sponsor
Eagle Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03324061
Collaborator
(none)
600
Enrollment
12
Locations
2
Arms
7.4
Actual Duration (Months)
50
Patients Per Site
6.8
Patients Per Site Per Month

Study Details

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
  • 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
Actual 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 :
Nov 30, 2017
Actual Primary Completion Date :
Jul 12, 2018
Actual Study Completion Date :
Jul 12, 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 [Day 0 through Day 140]

    Area under the concentration-time curve(AUC)

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Site City State Country Postal Code
1 Collaborative Neuroscience Network, LLC Long Beach California United States 90806
2 Avail Clinical Research, LLC DeLand Florida United States 32720
3 Clinical Pharmacology of Miami, LLC Miami Florida United States 33014
4 Quotient Sciences Miami Florida United States 33126
5 Advanced Pharma CR, LLC Miami Florida United States 33147
6 Orlando Clinical Research Center Orlando Florida United States 32809
7 Clinical Research Consortium Las Vegas Nevada United States 89119
8 Hassman Research Institute Berlin New Jersey United States 08009
9 New Horizon Clinical Research Cincinnati Ohio United States 45242
10 New Orleans Center for Clinical Research Knoxville Tennessee United States 37920
11 Optimal Research, LLC Austin Texas United States 78705
12 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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eagle Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT03324061
Other Study ID Numbers:
  • EGL-5835-C-1701
First Posted:
Oct 27, 2017
Last Update Posted:
Jun 3, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
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

Study Results

No Results Posted as of Jun 3, 2021