Healthy
Conditions
Keywords
Pharmacokinetics
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.
Interventions
DRUG25 mg Proellex
25 mg - given as one 25 mg capsule (252 mg of Gelucire and 88 mg of PEG400, original formulation) \[Original\], single dose
DRUG50 mg Proellex
50 mg - given as two 25 mg capsules (blended with microcrystalline cellulose, new formulation) \[Blended\], single dose
Sponsors
Repros Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proellex peak plasma concentration (Cmax) | 24 hours |
| Proellex time to peak plasma concentration (tmax). | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed