- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00620503
Proellex® Pharmacokinetic Bridging Study II (PK)
June 20, 2019 updated by: Repros Therapeutics Inc.
An open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years.
Twelve female subjects will each receive a single dose of Proellex®: 25 mg (fed state, formulation A), 25 mg (fed state, formulation B), and 25 mg (fasting state, formulation B); successive dosing will be separated by at least one week intervals from the previous dosing.
Blood will be collected prior to taking the dose, and following the dose for 24 hours post-dose.
Subjects will be discharged from the study after the last blood sample is obtained after the third dose of Proellex®.
Safety will be assessed throughout the study.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78209
- Healthcare Discoveries Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 34 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Subject must be able to speak, read and understand English and be willing and able to provide written informed consent on an Institutional Review Board (IRB)-approved form prior to the initiation of any study procedures. Subject must have signed and dated a written Informed Consent Form (ICF) before undergoing any study related activities, including discontinuation of any prohibited medications
- Premenopausal women aged 18 - 34 inclusive with body mass index between 18 and 35 inclusive
- Women of child-bearing potential must be willing to use effective non-hormonal, double-barrier method contraception during the study period and for a minimum of 30 days after discontinuation of the study medication. Women who have had a hysterectomy will be allowed into the study
- Must have a negative urine pregnancy test at screening
- Able to swallow gelatin capsules
- In general good health
- Must have agreed to not attempt to become pregnant at any time during study participation or for 30 days thereafter
- Must not have used tobacco (nicotine products) for at least two years before the study starts
- Must have normal (or abnormal and clinically insignificant) laboratory values at screening
- Willing to remain in the clinic for the screening visit and for the treatment visits
- Available for all treatment and follow-up visits
- Willing to comply with all study procedures
- Additional inclusion criteria may apply
Exclusion Criteria:
- Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study
- Past or present history of experiencing any allergic reaction to the formulations administered in this study, or in the opinion of the Principal Investigator, suggests an increased potential for an adverse hypersensitivity
- Any medical condition, which, in the judgment of the Principal Investigator, will prevent the subject from starting and/or completing the study
- Past or present history of any significant cardiovascular, renal, hepatic disease, thrombophlebitis, thromboembolic disorders, or cerebrovascular accident requiring ongoing medical therapy or clinical intervention
- A QTc interval of >450ms at screening
- Subject with abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Principal Investigator
- Subjects with symptomatic uterine fibroids or endometriosis
- Use of other oral contraceptives or hormonal treatments within 30 days of first dose of study medication
- Use of a hormone-releasing intrauterine device
- Subject with a history of alcohol and/or drug abuse
- Known active infection of HIV, Hepatitis A, B or C
- Subject who has participated in a clinical trial with investigational medication within 30 days prior to study medication administration or who plans to take an experimental drug prior to the end of 30 days after participation in this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Formulation A Fed
Single dose of Proellex 25 mg formulation A, fed
|
One Proellex 25 mg formulation A capsule
Other Names:
|
EXPERIMENTAL: Formulation B Fed
Single dose of Proellex 25 mg formulation B, fed
|
One 25 mg Proellex capsule formulation B administered both fed and fasted
Other Names:
|
EXPERIMENTAL: Formulation B Fasted
Single dose of Proellex 25 mg formulation B, fasted
|
One 25 mg Proellex capsule formulation B administered both fed and fasted
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax of Proellex
Time Frame: 24 hours
|
Maximum observed concentration (Cmax) of a single dose of Proellex® (25 mg) Formulation A using two different formulations of the drug in healthy adult female subjects with or without fasting
|
24 hours
|
AUC0-last of Proellex
Time Frame: Up to 24 hours
|
Area under the plasma concentration curve from time 0 (AUC0-last) to the last measurable plasma concentration time point, up to 24 hours.
|
Up to 24 hours
|
Tmax
Time Frame: 24 hours
|
Time to maximum plasma occurrence of Cmax
|
24 hours
|
AUC0-infinity of Proellex
Time Frame: 24 hours
|
Area under the plasma concentration curve from time 0 to extrapolated to infinity, calculated by summing the area under the curve from time zero to the time of the last quantifiable concentration
|
24 hours
|
Terminal Elimination Half-life (T1/2) of Proellex
Time Frame: 24 hours
|
Time to maximum plasma occurrence of T1/2, calculated as ln(2)/Elimination rate constant.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Anne Chan, Allergan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 29, 2008
Primary Completion (ACTUAL)
April 30, 2008
Study Completion (ACTUAL)
April 30, 2008
Study Registration Dates
First Submitted
February 4, 2008
First Submitted That Met QC Criteria
February 20, 2008
First Posted (ESTIMATE)
February 21, 2008
Study Record Updates
Last Update Posted (ACTUAL)
June 21, 2019
Last Update Submitted That Met QC Criteria
June 20, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ZP-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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