A Safety and Pharmacokinetic Study of Proellex®

NCT00619385 | Completed Phase 1 Results

• 1 other identifier: ZP-003
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Dose escalating study of 7 daily doses of Proellex at 100 mg, 150 mg and 200 mg

Conditions

Healthy

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Cmax Post Final Dose

  To determine the safety and PK properties of 100 mg, 150 mg and 200 mg of Proellex® taken for seven days by healthy adult female subjects.

  7 days

• AUC Post Final Dose

  7 days

Study Arms (3)

Proellex 100 mg

EXPERIMENTAL

Proellex 100 mg daily for 7 days

Drug: Proellex

Proellex 150 mg

EXPERIMENTAL

Proellex 150 mg daily for 7 days

Drug: Proellex

Proellex 200 mg

EXPERIMENTAL

Proellex 200 mg daily for 7 days

Drug: Proellex

Interventions

Proellex DRUG

Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days

Also known as: Telapristone acetate

Proellex 100 mg; Proellex 150 mg; Proellex 200 mg

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Repros Therapeutics Inc.: lead

Study Sites (1)

Healthcare Discoveries Inc.

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Interventions

telapristone acetate

Results Point of Contact

• Title: Jennifer Wike
• Organization: Repros Therapeutics

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
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 21, 2008
• Study Start: February 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 8, 2014
• Results First Posted: July 28, 2014

Record last verified: 2014-08

Locations

US (1)