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Proellex Pharmacokinetics Bridging Study

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ClinicalTrials.gov Identifier: NCT01067807
Recruitment Status : Completed
First Posted : February 12, 2010
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE February 10, 2010
First Posted Date  ICMJE February 12, 2010
Last Update Posted Date July 8, 2014
Study Start Date  ICMJE June 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2010)
  • Proellex peak plasma concentration (Cmax) [ Time Frame: 24 hours ]
  • Proellex time to peak plasma concentration (tmax). [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01067807 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2010)
  • 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 ]
  • The area under the plasma concentration over time curve from zero to infinity (AUC 0-infinity). [ Time Frame: 24 hours ]
  • Terminal elimination half-life (t1/2). [ Time Frame: 24 hours ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Proellex Pharmacokinetics Bridging Study
Official Title  ICMJE Proellex Pharmacokinetics Bridging Study
Brief Summary Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Proellex Formulation 1
    25 mg Proellex Gelucire and PEG (original formulation)
    Intervention: Drug: 25 mg Proellex
  • Experimental: 25 mg Proellex Formulation 2
    25 mg Proellex coated with MCC
    Intervention: Drug: 25 mg Proellex
  • Experimental: 25 mg Proellex Formulation 3
    25 mg Proellex blended with MCC
    Intervention: Drug: 25 mg Proellex
  • Experimental: 50 mg Proellex Formulation 3
    50 mg Proellex blended with MCC
    Intervention: Drug: 50 mg Proellex
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2010)
21
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01067807
Other Study ID Numbers  ICMJE ZP-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Repros Therapeutics Inc.
Study Sponsor  ICMJE Repros Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Andre van As, PhD, MD Repros Therapeutics Inc.
PRS Account Repros Therapeutics Inc.
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP