Proellex Pharmacokinetics Bridging Study
1 other identifier
interventional
21
1 country
1
Brief Summary
Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Jun 2007
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 10, 2010
CompletedFirst Posted
Study publicly available on registry
February 12, 2010
CompletedJuly 8, 2014
July 1, 2014
1 month
February 10, 2010
July 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proellex peak plasma concentration (Cmax)
24 hours
Proellex time to peak plasma concentration (tmax).
24 hours
Secondary Outcomes (4)
The area under the plasma concentration over time curve from zero to the last measurable Proellex plasma concentration (AUC0-24) was calculated.
24 hours
The area under the plasma concentration over time curve from zero to infinity (AUC 0-infinity).
24 hours
Terminal elimination half-life (t1/2).
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.
24 hours
Study Arms (4)
Proellex Formulation 1
EXPERIMENTAL25 mg Proellex Gelucire and PEG (original formulation)
25 mg Proellex Formulation 2
EXPERIMENTAL25 mg Proellex coated with MCC
25 mg Proellex Formulation 3
EXPERIMENTAL25 mg Proellex blended with MCC
50 mg Proellex Formulation 3
EXPERIMENTAL50 mg Proellex blended with MCC
Interventions
25 mg - given as one 25 mg capsule (252 mg of Gelucire and 88 mg of PEG400, original formulation) \[Original\], single dose
50 mg - given as two 25 mg capsules (blended with microcrystalline cellulose, new formulation) \[Blended\], single dose
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Post-menopausal women,
- Subject with documented endometriosis
- Subject with known uterine fibroids or vaginal polyps
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Healthcare Discoveries, Inc
San Antonio, Texas, 78209, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Andre van As, PhD, MD
Repros Therapeutics Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2010
First Posted
February 12, 2010
Study Start
June 1, 2007
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
July 8, 2014
Record last verified: 2014-07