Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females

Study Overview
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Brief Summary
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PK and safety profile of Proellex® in females with various stages of impaired renal function

Detailed Description
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The study will evaluate the pharmacokinetics and safety profile of Proellex® in females with various stages of impaired renal function and in volunteers with normal renal function

Official Title
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A Single-Dose, Open-Label, Parallel Group Study To Evaluate The Pharmacokinetics And Safety Profile Of PROELLEX® (CDB-4124) In Female Subjects With Various Stages Of Impaired Renal Function And In Healthy Female Volunteers

Conditions
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Renal Impairment

Intervention / Treatment
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* Drug: 50 mg Proellex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures; Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive, is preferred Subject must meet the criteria of mildly or moderately impaired renal function or have normal renal function Subject with renal impairment must have evidence of stable disease If on medications for treatment of the complications of renal disease, and other concommitant chronic illnesses, subject must have been taking the medications at a stable dose for at least 10 days prior to the first Proellex® dosing date and are then to be continued at the same dose for the duration of the study. Negative urine pregnancy test at screening visit Subject must agree to use a medically acceptable and effective non-hormonal double barrier method of birth control Healthy subject must have no significant abnormal findings at the screening physical examination Subject is willing to remain in the clinic for the screening visit (approximately 1 day for the first screening visit) and for the treatment visit (approximately 3 days) Additional inclusion criteria may apply Exclusion Criteria: Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant Subject with clinically significant abnormal liver function Pregnant or lactating females, or women who are attempting or expecting to become pregnant at any time during the study or one month after the study An acute illness within five (5) days of study medication administration Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system Additional exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 50 mg Proellex Mild impairment<br>50 mg Proellex single dose Female subjects with mild renal impairment function. | Drug: 50 mg Proellex<br>* Single dose<br>* Other names: Proellex;|
| Active Comparator: 50 mg Proellex Moderate<br>50 mg Proellex, Female subjects with moderate renal impairment function. | Drug: 50 mg Proellex<br>* Single dose<br>* Other names: Proellex;|
| Active Comparator: 50 mg Proellex, Normal<br>50 mg Proellex, Female subjects with normal renal function. | Drug: 50 mg Proellex<br>* Single dose<br>* Other names: Proellex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of Proellex |  | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal impairment