Renal Impairment
Conditions
Keywords
Renal impairment
Brief summary
PK and safety profile of Proellex® in females with various stages of impaired renal function
Detailed description
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
Interventions
DRUG50 mg Proellex
Single dose
Sponsors
Repros Therapeutics Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of Proellex | 48 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 50 mg Proellex Mild Impairment 50 mg Proellex single dose Female subjects with mild renal impairment function.
50 mg Proellex: Single dose | 0 |
| 50 mg Proellex Moderate 50 mg Proellex, Female subjects with moderate renal impairment function.
50 mg Proellex: Single dose | 0 |
| 50 mg Proellex, Normal 50 mg Proellex, Female subjects with normal renal function.
50 mg Proellex: Single dose | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | — Participants |
| Age, Categorical >=65 years | — Participants |
| Age, Categorical Between 18 and 65 years | — Participants |
| Region of Enrollment United States | — participants |
| Sex: Female, Male Female | — Participants |
| Sex: Female, Male Male | — Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Cmax of Proellex
Time frame: 48 hours
Population: Study prematurely terminated