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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-07-31

Brief Summary

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PK and safety profile of Proellex® in females with various stages of impaired renal function

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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

Conditions

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Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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50 mg Proellex Mild impairment

50 mg Proellex single dose Female subjects with mild renal impairment function.

Group Type ACTIVE_COMPARATOR

50 mg Proellex

Intervention Type DRUG

Single dose

50 mg Proellex Moderate

50 mg Proellex, Female subjects with moderate renal impairment function.

Group Type ACTIVE_COMPARATOR

50 mg Proellex

Intervention Type DRUG

Single dose

50 mg Proellex, Normal

50 mg Proellex, Female subjects with normal renal function.

Group Type ACTIVE_COMPARATOR

50 mg Proellex

Intervention Type DRUG

Single dose

Interventions

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50 mg Proellex

Single dose

Intervention Type DRUG

Other Intervention Names

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Telapristone acetate Proellex

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)

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes