Proellex Pharmacokinetics Bridging Study

This study has been completed.
Sponsor:
Information provided by:
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01067807
First received: February 10, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: 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: 1
Proellex
Drug: Proellex
25 mg - given as one 25 mg capsule (252 mg of Gelucire and 88 mg of PEG400, original formulation) [Original], single dose
Other Name: CDB-4124
Experimental: 2
Proellex
Drug: Proellex
25 mg - given as one 25 mg capsule (coated with microcrystalline cellulose, new formulation) (coated), single dose
Other Name: CDB-4124
Experimental: 3
Proellex
Drug: Proellex
25 mg - given as one 25 mg capsule (blended with microcrystalline cellulose, new formulation) [Blended], single dose
Other Name: CDB-4124
Experimental: 4
Proellex
Drug: Proellex
50 mg - given as two 25 mg capsules (blended with microcrystalline cellulose, new formulation) [Blended], single dose
Other Name: CDB-4124

  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
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: Andre van As M.D. Ph.D., Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01067807     History of Changes
Other Study ID Numbers: ZP-001
Study First Received: February 10, 2010
Last Updated: February 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:
Pharmacokinetics

ClinicalTrials.gov processed this record on April 21, 2014