Proellex® Pharmacokinetic Bridging Study II (PK)

This study has been completed.
Sponsor:
Information provided by:
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00620503
First received: February 4, 2008
Last updated: February 8, 2010
Last verified: February 2010
  Purpose

This is an open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years. Twelve female subjects will each receive a single dose of Proellex®: 25 mg (fed state, formulation A), 25 mg (fed state, formulation B), and 25 mg (fasting state, formulation B); successive dosing will be separated by at least one week intervals from the previous dosing. Blood will be collected prior to taking the dose, and following the dose for 24 hours post-dose. Subjects will be discharged from the study after the last blood sample is obtained after the third dose of Proellex®. Safety will be assessed throughout the study.


Condition Intervention Phase
Healthy
Drug: Proellex 25 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Proellex® Pharmacokinetic Bridging Study II

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • To determine and compare the pharmacokinetic (PK) properties of a single dose of Proellex® (25 mg) using two different formulations of the drug in healthy adult female subjects with or without fasting [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine and compare the safety of a single dose of Proellex® (25 mg) using two formulations of the drug in healthy adult female subjects with or without fasting [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: February 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Proellex 25 mg formulation A
Drug: Proellex 25 mg
One Proellex 25 mg capsule for one day administered after being fed
Experimental: B
Proellex 25 mg formulation B
Drug: Proellex 25 mg
One Proellex 25 mg capsule for one day administered after being fed
Experimental: C
Proellex 25 mg formulation B
Drug: Proellex 25 mg
One 25 mg Proellex capsule for one day administered while fasting

  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • Additional inclusion criteria may apply

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620503

Locations
United States, Texas
Healthcare Discoveries Inc.
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
Study Director: Andre vanAs, MD, PhD Repros Therapeutics Inc.
  More Information

No publications provided

Responsible Party: Andre vanAs, MD, PhD, Repros Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00620503     History of Changes
Other Study ID Numbers: ZP-002
Study First Received: February 4, 2008
Last Updated: February 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:
PK
Pharmacokinetics

ClinicalTrials.gov processed this record on September 16, 2014