Proellex Pharmacokinetics Bridging Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01067807
First received: February 10, 2010
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations


Condition Intervention Phase
Healthy
Drug: 25 mg Proellex
Drug: 50 mg Proellex
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 Pharmacokinetics Bridging Study

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • Proellex peak plasma concentration (Cmax) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Proellex time to peak plasma concentration (tmax). [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The area under the plasma concentration over time curve from zero to the last measurable Proellex plasma concentration (AUC0-24) was calculated. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • The area under the plasma concentration over time curve from zero to infinity (AUC 0-infinity). [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Terminal elimination half-life (t1/2). [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Vital signs evaluated at screening, treatment days 0 and 1. Clinical laboratory values obtained at screening, treatment days 0 and 1. Adverse events assessed at treatment visits and followed until resolution. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: June 2007
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proellex Formulation 1
25 mg Proellex Gelucire and PEG (original formulation)
Drug: 25 mg Proellex
25 mg - given as one 25 mg capsule (252 mg of Gelucire and 88 mg of PEG400, original formulation) [Original], single dose
Other Names:
  • CDB-4124
  • Telapristone acetate
Experimental: 25 mg Proellex Formulation 2
25 mg Proellex coated with MCC
Drug: 25 mg Proellex
25 mg - given as one 25 mg capsule (coated with microcrystalline cellulose, new formulation) (coated), single dose
Other Name: CDB-4124
Experimental: 25 mg Proellex Formulation 3
25 mg Proellex blended with MCC
Drug: 25 mg Proellex
25 mg - given as one 25 mg capsule (blended with microcrystalline cellulose, new formulation) [Blended], single dose
Other Name: CDB-4124
Experimental: 50 mg Proellex Formulation 3
50 mg Proellex blended with MCC
Drug: 50 mg Proellex
50 mg - given as two 25 mg capsules (blended with microcrystalline cellulose, new formulation) [Blended], single dose
Other Name: CDB-4124

Detailed Description:

Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations (24 and 50 mg dose). Blood was collected pre-dose, at specified intervals and 24 hours post dose. Each dose was separated by at least one week interval from the previous dose.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the clinical Investigator
  • Subject was willing to remain in the clinic for the screening visit; and for the treatment visits (day -1, day of treatment and day 1; approximately 36 hrs per treatment visit)

Exclusion Criteria:

  • Post-menopausal women,
  • Subject with documented endometriosis
  • Subject with known uterine fibroids or vaginal polyps
  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: NCT01067807

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

No publications provided

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01067807     History of Changes
Other Study ID Numbers: ZP-001
Study First Received: February 10, 2010
Last Updated: July 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:
Pharmacokinetics

ClinicalTrials.gov processed this record on October 19, 2014