Study to Evaluate the Safety, Tolerability, and PK of Fulvestrant After IM Administration
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| ClinicalTrials.gov Identifier: NCT03324061 |
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Recruitment Status :
Completed
First Posted : October 27, 2017
Last Update Posted : June 3, 2021
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Sponsor:
Eagle Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Eagle Pharmaceuticals, Inc.
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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 |
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 : | Interventional (Clinical Trial) |
| 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 : | November 30, 2017 |
| Actual Primary Completion Date : | July 12, 2018 |
| Actual Study Completion Date : | July 12, 2018 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Fulvestrant
| Arm | Intervention/treatment |
|---|---|
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Experimental: Fulvestrant for Injectable Suspension
Fulvestrant for Injectable Suspension (500 mg/vial)
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Drug: Fulvestrant for Injectable Suspension
Test drug is administered as a single 5mL intramuscular injection in the right or left dorsogluteal muscle area |
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Active Comparator: Faslodex (R)
Faslodex (250 mg/mL)
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Drug: Faslodex (Reference)
Reference drug is administered as two 5mL intramuscular injections, one in each of the right and left dorsogluteal muscle areas |
Primary Outcome Measures :
- Pharmacokinetic parameters [ Time Frame: Day 0 through Day 140 ]Area under the concentration-time curve(AUC)
Information from the National Library of Medicine
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| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324061
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. |
| Responsible Party: | Eagle Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT03324061 |
| Other Study ID Numbers: |
EGL-5835-C-1701 |
| First Posted: | October 27, 2017 Key Record Dates |
| Last Update Posted: | June 3, 2021 |
| Last Verified: | June 2021 |
| 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:
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Fulvestrant Antineoplastic Agents, Hormonal Antineoplastic Agents Estrogen Receptor Antagonists |
Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |