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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03324061
Recruitment Status : Completed
First Posted : October 27, 2017
Last Update Posted : June 3, 2021
Sponsor:
Information provided by (Responsible Party):
Eagle Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE October 24, 2017
First Posted Date  ICMJE October 27, 2017
Last Update Posted Date June 3, 2021
Actual Study Start Date  ICMJE November 30, 2017
Actual Primary Completion Date July 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2017)
Pharmacokinetic parameters [ Time Frame: Day 0 through Day 140 ]
Area under the concentration-time curve(AUC)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety, Tolerability, and PK of Fulvestrant After IM Administration
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Pharmacokinetics
Intervention  ICMJE
  • Drug: Fulvestrant for Injectable Suspension
    Test drug is administered as a single 5mL intramuscular injection in the right or left dorsogluteal muscle area
  • Drug: Faslodex (Reference)
    Reference drug is administered as two 5mL intramuscular injections, one in each of the right and left dorsogluteal muscle areas
Study Arms  ICMJE
  • Experimental: Fulvestrant for Injectable Suspension
    Fulvestrant for Injectable Suspension (500 mg/vial)
    Intervention: Drug: Fulvestrant for Injectable Suspension
  • Active Comparator: Faslodex (R)
    Faslodex (250 mg/mL)
    Intervention: Drug: Faslodex (Reference)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2017)
600
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 12, 2018
Actual Primary Completion Date July 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03324061
Other Study ID Numbers  ICMJE EGL-5835-C-1701
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Eagle Pharmaceuticals, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eagle Pharmaceuticals, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Adrian J Hepner, MD, PhD Eagle Pharmaceuticals, Inc.
PRS Account Eagle Pharmaceuticals, Inc.
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP