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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proellex Formulation 1 | Experimental | 25 mg Proellex Gelucire and PEG (original formulation) |
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| 25 mg Proellex Formulation 2 | Experimental | 25 mg Proellex coated with MCC |
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| 25 mg Proellex Formulation 3 | Experimental | 25 mg Proellex blended with MCC |
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| 50 mg Proellex Formulation 3 | Experimental | 50 mg Proellex blended with MCC |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 25 mg Proellex | Drug | 25 mg - given as one 25 mg capsule (252 mg of Gelucire and 88 mg of PEG400, original formulation) [Original], single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proellex peak plasma concentration (Cmax) | 24 hours | |
| Proellex time to peak plasma concentration (tmax). | 24 hours |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andre van As, PhD, MD | Repros Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthcare Discoveries, Inc | San Antonio | Texas | 78209 | United States |
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| ID | Term |
|---|---|
| C461063 | telapristone acetate |
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| 25 mg Proellex | Drug | 25 mg - given as one 25 mg capsule (coated with microcrystalline cellulose, new formulation) (coated), single dose |
|
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| 25 mg Proellex | Drug | 25 mg - given as one 25 mg capsule (blended with microcrystalline cellulose, new formulation) [Blended], single dose |
|
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| 50 mg Proellex | Drug | 50 mg - given as two 25 mg capsules (blended with microcrystalline cellulose, new formulation) [Blended], single dose |
|
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| 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 |