Proellex Pharmacokinetics Bridging Study

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

Detailed Description
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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.

Official Title
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Proellex Pharmacokinetics Bridging Study

Conditions
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Healthy

Intervention / Treatment
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* Drug: 25 mg Proellex
* Drug: 25 mg Proellex
* Drug: 25 mg Proellex
* Drug: 50 mg Proellex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proellex Formulation 1<br>25 mg Proellex Gelucire and PEG (original formulation) | Drug: 25 mg Proellex<br>* 25 mg - given as one 25 mg capsule (252 mg of Gelucire and 88 mg of PEG400, original formulation) [Original], single dose<br>* Other names: Telapristone acetate;|
| Experimental: 25 mg Proellex Formulation 2<br>25 mg Proellex coated with MCC | Drug: 25 mg Proellex<br>* 25 mg - given as one 25 mg capsule (coated with microcrystalline cellulose, new formulation) (coated), single dose<br>* Other names: CDB-4124;|
| Experimental: 25 mg Proellex Formulation 3<br>25 mg Proellex blended with MCC | Drug: 25 mg Proellex<br>* 25 mg - given as one 25 mg capsule (blended with microcrystalline cellulose, new formulation) [Blended], single dose<br>* Other names: CDB-4124;|
| Experimental: 50 mg Proellex Formulation 3<br>50 mg Proellex blended with MCC | Drug: 50 mg Proellex<br>* 50 mg - given as two 25 mg capsules (blended with microcrystalline cellulose, new formulation) [Blended], single dose<br>* Other names: CDB-4124;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proellex peak plasma concentration (Cmax) |  | 24 hours | 
| Proellex time to peak plasma concentration (tmax). |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics