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Study to evaluate the PK of 25 mg and 50 mg of Proellex from 2 different suppliers in the fed and fasting states.
This study is intended to evaluate the pharmacokinetic properties of two doses (25 mg and 50 mg) of Proellex® formulated with microcrystalline cellulose (MCC) from 2 different suppliers in the fed and fasting states.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25 mg AMCC fed | Experimental | 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fed State |
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| 25 mg AMCC fasting | Experimental | 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fasting State |
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| 50 mg AMCC fed | Experimental | 2, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fed State |
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| 50 mg AMCC fasting | Experimental | 2, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fasting State |
|
| 50 mg SMCC fasting | Experimental | 2, 25 mg Proellex capsules formulated with SMCC microcrystalline cellulose Fasting State |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proellex | Drug | 25 mg capsule administered once orally after subjects have been fed; 25 mg capsule administered once orally while subjects are fasting; 2, 25 mg capsules administered once orally after subjects have been fed; 2, 25 mg capsules administered once orally while subjects are fasting; and 2, 25 mg capsules administered once orally while subjects are fasting |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Proellex | Maximum observed concentration of Proellex | Up to 72 hours post-dose |
| AUC0-last of Proellex | Area under the plasma concentration curve from time 0 to the last measurable plasma concentration time point, up to 72 hours. | Up to 72 hours post dose |
| Tmax of Proellex | Time to maximum plasma occurrence of Cmax | Up to 72 hours post dose |
| AUC0-infinity of Proellex | Area under the plasma concentration curve from time 0 to extrapolated to infinity, calculated by summing the area under the curve from time zero to the time of the last quantifiable concentration | Up to 72 hours post dose |
| Terminal Elimination Half-life (T1/2) of Proellex | Time to maximum plasma occurrence of T1/2, calculated as ln(2)/Elimination rate constant. | Up to 72 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Chan | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthcare Discoveries Inc. | San Antonio | Texas | 78229 | United States |
Each of the 12 participants were randomly assigned a unique sequence of the following 5 following open-label treatments of Proellex
Of the 17 participants, 4 did not meet inclusion/exclusion criteria, and 1 participant enrolled as a spare was not needed, resulting in their involvement in the study being terminated. The remaining 12 participants completed all five study treatments of Proellex.
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| ID | Title | Description |
|---|---|---|
| FG000 | Proellex | in randomly assigned sequences, all study participants received 5 open-label treatments of Proellex: 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fed State Proellex; 25 mg capsule administered once orally after subjects have been fed; 25 mg capsule administered once orally while subjects are fasting; 2, 25 mg capsules administered once orally after subjects have been fed; 2, 25 mg capsules administered once orally while subjects are fasting; and 2, 25 mg capsules administered once orally while subjects are fasting |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All subjects enrolled
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects enrolled |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax of Proellex | Maximum observed concentration of Proellex | 12 subjects received all 5 treatments | Posted | Mean | Standard Deviation | ng/mL | Up to 72 hours post-dose |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 25 mg AMCC Fed | 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fed State |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Repros Therapeutics Inc, an Allergan Affiliate | 714-246-4500 | IR-CTRegistration@allergan.com |
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| ID | Term |
|---|---|
| C461063 | telapristone acetate |
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|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fed State
| OG003 | 50 mg AMCC Fasting | Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fasting State |
| OG004 | 50 mg SMCC Fasting | Two, 25 mg Proellex capsules formulated with SMCC microcrystalline cellulose Fasting State |
|
|
| Primary | AUC0-last of Proellex | Area under the plasma concentration curve from time 0 to the last measurable plasma concentration time point, up to 72 hours. | All 12 subjects received each treatment | Posted | Mean | Standard Deviation | ng/mL*hour | Up to 72 hours post dose |
|
|
|
| Primary | Tmax of Proellex | Time to maximum plasma occurrence of Cmax | All 12 subjects received each treatment | Posted | Mean | Standard Deviation | Hours | Up to 72 hours post dose |
|
|
|
| Primary | AUC0-infinity of Proellex | Area under the plasma concentration curve from time 0 to extrapolated to infinity, calculated by summing the area under the curve from time zero to the time of the last quantifiable concentration | All 12 subjects received each treatment | Posted | Mean | Standard Deviation | ng/mL*hour | Up to 72 hours post dose |
|
|
|
| Primary | Terminal Elimination Half-life (T1/2) of Proellex | Time to maximum plasma occurrence of T1/2, calculated as ln(2)/Elimination rate constant. | All 12 subjects received each treatment | Posted | Mean | Standard Deviation | Hours | Up to 72 hours post dose |
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | 25 mg AMCC Fasting | 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fasting State | 0 | 12 | 2 | 12 |
| EG002 | 50 mg AMCC Fed | Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fed State | 0 | 12 | 4 | 12 |
| EG003 | 50 mg AMCC Fasting | Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fasting State | 0 | 12 | 7 | 12 |
| EG004 | 50 mg SMCC Fasting | Two, 25 mg Proellex capsules formulated with SMCC microcrystalline cellulose Fasting State | 0 | 12 | 5 | 12 |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Pelvi pain NOS | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Nipple pain | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Oligomenorrhea | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
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