Proellex Pharmacokinetics Bridging Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-07-31

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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Proellex Formulation 1

25 mg Proellex Gelucire and PEG (original formulation)

Group Type EXPERIMENTAL

25 mg Proellex

Intervention Type DRUG

25 mg - given as one 25 mg capsule (252 mg of Gelucire and 88 mg of PEG400, original formulation) \[Original\], single dose

25 mg Proellex Formulation 2

25 mg Proellex coated with MCC

Group Type EXPERIMENTAL

25 mg Proellex

Intervention Type DRUG

25 mg - given as one 25 mg capsule (coated with microcrystalline cellulose, new formulation) (coated), single dose

25 mg Proellex Formulation 3

25 mg Proellex blended with MCC

Group Type EXPERIMENTAL

25 mg Proellex

Intervention Type DRUG

25 mg - given as one 25 mg capsule (blended with microcrystalline cellulose, new formulation) \[Blended\], single dose

50 mg Proellex Formulation 3

50 mg Proellex blended with MCC

Group Type EXPERIMENTAL

50 mg Proellex

Intervention Type DRUG

50 mg - given as two 25 mg capsules (blended with microcrystalline cellulose, new formulation) \[Blended\], single dose

Interventions

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25 mg Proellex

25 mg - given as one 25 mg capsule (252 mg of Gelucire and 88 mg of PEG400, original formulation) \[Original\], single dose

Intervention Type DRUG

25 mg Proellex

25 mg - given as one 25 mg capsule (coated with microcrystalline cellulose, new formulation) (coated), single dose

Intervention Type DRUG

25 mg Proellex

25 mg - given as one 25 mg capsule (blended with microcrystalline cellulose, new formulation) \[Blended\], single dose

Intervention Type DRUG

50 mg Proellex

50 mg - given as two 25 mg capsules (blended with microcrystalline cellulose, new formulation) \[Blended\], single dose

Intervention Type DRUG

Other Intervention Names

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CDB-4124 Telapristone acetate CDB-4124 CDB-4124 CDB-4124

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)