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

NCT00787618 | Terminated Phase 1 Results

• 1 other identifier: ZP-006
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Renal Impairment

Keywords

Renal impairment

Outcome Measures

Primary Outcomes (1)

• Cmax of Proellex

  48 hours

Study Arms (3)

50 mg Proellex Mild impairment

ACTIVE COMPARATOR

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

Drug: 50 mg Proellex

50 mg Proellex Moderate

ACTIVE COMPARATOR

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

Drug: 50 mg Proellex

50 mg Proellex, Normal

ACTIVE COMPARATOR

50 mg Proellex, Female subjects with normal renal function.

Drug: 50 mg Proellex

Interventions

50 mg Proellex DRUG

Single dose

Also known as: Telapristone acetate, Proellex

50 mg Proellex Mild impairment; 50 mg Proellex Moderate; 50 mg Proellex, Normal

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Repros Therapeutics Inc.: lead

Study Sites (4)

Clinical Pharmacology of Miami, Inc

Miami, Florida, 33014-3616, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

New Orleans Center for Clinical Research - Knoxville

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

telapristone acetate

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

The study was prematurely terminated for safety reasons (Proellex studies were put on clinical hold due to liver toxicity). Sponsor was unable to pay vendor, and was therefore not provided with any study data.

Results Point of Contact

• Title: Jennifer Wike
• Organization: Repros Therapeutics Inc.

jwike@reprosrx.com

2817193402

Study Officials

• Andre van As, MD, PhD

  Repros Therapeutics Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: November 7, 2008
• Study Start: October 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: August 25, 2014
• Results First Posted: August 25, 2014

Record last verified: 2014-08

Locations

US (4)