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This study is a double-blind crossover study in female healthy volunteers to compare the pharmacokinetics and safety of a single dose each of two different formulations of Proellex for oral administration. Each formulation will be designated as either Treatment A or Treatment B. A total of 12 subjects who meet the eligibility criteria will be randomized to receive either Treatment A or Treatment B as their first assigned treatment. After a 7-day washout period subjects will receive the alternative treatment. On the day of each treatment subjects will remain in the clinic overnight and undergo 72-hour pharmacokinetic assessment at the following time points: 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 and 72 hours after administration of study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telapristone Acetate, Proellex Formulation A (Treatment A) | Experimental | Subjects who meet the eligibility criteria will be randomized to receive either 12 mg Treatment A or 12 mg Treatment B as their first assigned treatment. After a 7-day washout period subjects will receive the alternative treatment. |
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| Telapristone Acetate, Proellex Formulation B (Treatment B) | Experimental | Subjects who meet the eligibility criteria will be randomized to receive either 12 mg Treatment A or 12 mg Treatment B as their first assigned treatment. After a 7-day washout period subjects will receive the alternative treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telapristone Acetate, Proellex 12 mg Formulation A | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Comparison | To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations of 12 mg Proellex administered orally to female healthy volunteers. On the day of each treatment subjects will remain in the clinic overnight and undergo 72-hour pharmacokinetic assessment at the following time points: 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 and 72 hours after administration of study drug. Pharmacokinetic Endpoints
| Up to 2 weeks |
| Dose formulation safety | To determine and compare the safety of a single dose of each of two formulations of 12 mg Proellex administered orally to female healthy volunteers. After the completion of the study; incidence of adverse events, mean change from baseline of laboratory values (hematology, blood chemistry, urinalysis), mean change from baseline of vital signs will be assessed. Vital signs and adverse events will be recorded at each visit. | Up to 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| C461063 | telapristone acetate |
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| Telapristone Acetate, Proellex 12 mg Formulation B | Drug |
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