## Protocol Section
### Identification Module
**NCT ID:** NCT00749879

**Brief Title:** Crossover Study of the Safety and PK Properties of Proellex®

**Official Title:** A Phase I, Open-Label, Randomized, Single-Center, Unblinded, Single-Dose, Five-Way Crossover Study of the Safety and PK Properties of Proellex®

#### Organization Study ID Info
**ID:** ZP-008
#### Organization
**Class:** INDUSTRY
**Full Name:** Repros Therapeutics Inc.
### Status Module
#### Completion Date
**Date:** 2008-10-23

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-04-29

**Type:** ACTUAL

**Last Update Submit Date:** 2019-01-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-10-23

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-04-29

**Type:** ACTUAL

**Results First Submit Date:** 2014-07-03

**Results First Submit QC Date:** 2019-01-23

#### Start Date
**Date:** 2008-08-11

**Type:** ACTUAL

**Status Verified Date:** 2019-01

#### Study First Post Date
**Date:** 2008-09-09
**Type:** ESTIMATED
**Study First Submit Date:** 2008-09-05
**Study First Submit QC Date:** 2008-09-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Repros Therapeutics Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Study to evaluate the PK of 25 mg and 50 mg of Proellex from 2 different suppliers in the fed and fasting states.

**Detailed Description:** 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.

### Conditions Module

**Conditions:**

- Pharmacokinetics

**Keywords:**

- PK

- Pharmacokinetics

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 17

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose

Fed State

**Intervention Names:**

- Drug: Proellex

**Label:** 25 mg AMCC fed

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose

Fasting State

**Intervention Names:**

- Drug: Proellex

**Label:** 25 mg AMCC fasting

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** 2, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose

Fed State

**Intervention Names:**

- Drug: Proellex

**Label:** 50 mg AMCC fed

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** 2, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose

Fasting State

**Intervention Names:**

- Drug: Proellex

**Label:** 50 mg AMCC fasting

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** 2, 25 mg Proellex capsules formulated with SMCC microcrystalline cellulose

Fasting State

**Intervention Names:**

- Drug: Proellex

**Label:** 50 mg SMCC fasting

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 25 mg AMCC fasting

- 25 mg AMCC fed

- 50 mg AMCC fasting

- 50 mg AMCC fed

- 50 mg SMCC fasting

**Description:** 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

**Name:** Proellex

**Other Names:**

- Telapristone acetate

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Maximum observed concentration of Proellex

**Measure:** Cmax of Proellex

**Time Frame:** Up to 72 hours post-dose

**Description:** Area under the plasma concentration curve from time 0 to the last measurable plasma concentration time point, up to 72 hours.

**Measure:** AUC0-last of Proellex

**Time Frame:** Up to 72 hours post dose

**Description:** Time to maximum plasma occurrence of Cmax

**Measure:** Tmax of Proellex

**Time Frame:** Up to 72 hours post dose

**Description:** 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

**Measure:** AUC0-infinity of Proellex

**Time Frame:** Up to 72 hours post dose

**Description:** Time to maximum plasma occurrence of T1/2, calculated as ln(2)/Elimination rate constant.

**Measure:** Terminal Elimination Half-life (T1/2) of Proellex

**Time Frame:** Up to 72 hours post dose

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subject must be able to speak, read, and understand English and be willing and able to provide written informed consent in English on an Institutional Review Board (IRB)
* Premenopausal women aged 18-34, inclusive, with body mass index between 18 and 35, inclusive
* Women of child-bearing potential must be willing to use effective non-hormonal, double-barrier method contraception during the study period and for a minimum of 30 days after discontinuation of the study medication. Women who have had a hysterectomy will be allowed into the study
* Must have a negative urine pregnancy test at screening
* Able to swallow gelatin capsules
* Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the Principal Investigator that would interfere with the subject participating this study
* Must have agreed to not attempt to become pregnant at any time during study participation or for 30 days thereafter
* Other inclusion criteria may apply

Exclusion Criteria:

* Symptomatic uterine fibroids or endometriosis
* Past or present history of any significant cardiovascular, renal, or hepatic disease requiring ongoing medical therapy or clinical intervention
* Past or present history of thrombophlebitis, thromboembolic disorders, or cerebrovascular accident
* Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Principal Investigator
* Significant organ abnormality or disease (based on the Principal Investigator's judgment) that would in the opinion of the Principal Investigator exclude the subject from participating
* Other exclusion criteria may apply

**Healthy Volunteers:** True

**Maximum Age:** 34 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** San Antonio

**Country:** United States

**Facility:** Healthcare Discoveries Inc.

**State:** Texas

**Zip:** 78229

#### Overall Officials

**Official 1:**

**Affiliation:** Allergan

**Name:** Anna Chan

**Role:** STUDY_DIRECTOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** 25 mg AMCC Fed

**Description:** 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fed State

**ID:** EG000

**Other Num Affected:** 1

**Other Num at Risk:** 12

**Serious Number At Risk:** 12

**Title:** 25 mg AMCC Fed

**Group ID:** EG001

**Title:** 25 mg AMCC Fasting

**Description:** 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fasting State

**ID:** EG001

**Other Num Affected:** 2

**Other Num at Risk:** 12

**Serious Number At Risk:** 12

**Title:** 25 mg AMCC Fasting

**Group ID:** EG002

**Title:** 50 mg AMCC Fed

**Description:** Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fed State

**ID:** EG002

**Other Num Affected:** 4

**Other Num at Risk:** 12

**Serious Number At Risk:** 12

**Title:** 50 mg AMCC Fed

**Group ID:** EG003

**Title:** 50 mg AMCC Fasting

**Description:** Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fasting State

**ID:** EG003

**Other Num Affected:** 7

**Other Num at Risk:** 12

**Serious Number At Risk:** 12

**Title:** 50 mg AMCC Fasting

**Group ID:** EG004

**Title:** 50 mg SMCC Fasting

**Description:** Two, 25 mg Proellex capsules formulated with SMCC microcrystalline cellulose Fasting State

**ID:** EG004

**Other Num Affected:** 5

**Other Num at Risk:** 12

**Serious Number At Risk:** 12

**Title:** 50 mg SMCC Fasting

**Frequency Threshold:** 5

#### Other Events

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Hyperkalemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Presyncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Rhinitis allergic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Palpitations

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Pelvi pain NOS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Nipple pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Oligomenorrhea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA (Unspecified)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 12

**Units:** Participants

### Group

**ID:** BG000

**Title:** All Subjects

**Description:** All subjects enrolled

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 12

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 12

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 12

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Region of Enrollment
**Unit of Measure:** Participants
**Population Description:** All subjects enrolled
## Results Section - More Information Module
### Certain Agreement
**Other Details:** Prior to publication, Investigator shall submit to the Sponsor a copy of any proposed publication. Sponsor shall have sixty (60) days to review the proposed publication for possible disclosure of Sponsor's Confidential Information and, upon request of Sponsor, Investigator shall delete any of Sponsor's Confidential Information or withhold submission of such publication to allow Sponsor to protect its intellectual property rights
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** IR-CTRegistration@allergan.com
**Organization:** Repros Therapeutics Inc, an Allergan Affiliate
**Phone:** 714-246-4500
**Title:** Therapeutic Area Head
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 151.3
- **Upper Limit:** 
- **Value:** 485.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 201.9
- **Upper Limit:** 
- **Value:** 876.7
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 157.6
- **Upper Limit:** 
- **Value:** 912.9
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 154.5
- **Upper Limit:** 
- **Value:** 1322.5
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 148.5
- **Upper Limit:** 
- **Value:** 1346.7
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2845.9
- **Upper Limit:** 
- **Value:** 6142.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3036.6
- **Upper Limit:** 
- **Value:** 5765.7
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 4209.0
- **Upper Limit:** 
- **Value:** 11094.2
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 4217.5
- **Upper Limit:** 
- **Value:** 9252.0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 4328.3
- **Upper Limit:** 
- **Value:** 9576.2
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.6
- **Upper Limit:** 
- **Value:** 2.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.2
- **Upper Limit:** 
- **Value:** 0.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.0
- **Upper Limit:** 
- **Value:** 2.6
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.4
- **Upper Limit:** 
- **Value:** 0.9
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 0.2
- **Upper Limit:** 
- **Value:** 0.7
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3715.6
- **Upper Limit:** 
- **Value:** 7039.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4440.7
- **Upper Limit:** 
- **Value:** 6897.0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 6753.2
- **Upper Limit:** 
- **Value:** 13014.9
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 6726.6
- **Upper Limit:** 
- **Value:** 11271.6
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 7186.9
- **Upper Limit:** 
- **Value:** 11804.8
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8.2
- **Upper Limit:** 
- **Value:** 22.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 10.4
- **Upper Limit:** 
- **Value:** 25.2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 10.8
- **Upper Limit:** 
- **Value:** 23.8
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 11.8
- **Upper Limit:** 
- **Value:** 26.7
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 11.9
- **Upper Limit:** 
- **Value:** 27.5
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Maximum observed concentration of Proellex
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 12 subjects received all 5 treatments
**Reporting Status:** POSTED
**Time Frame:** Up to 72 hours post-dose
**Title:** Cmax of Proellex
**Type:** PRIMARY
**Unit of Measure:** ng/mL
##### Group
**Description:** 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fed State
**ID:** OG000
**Title:** 25 mg AMCC Fed
##### Group
**Description:** 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fasting State
**ID:** OG001
**Title:** 25 mg AMCC Fasting
##### Group
**Description:** Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fed State
**ID:** OG002
**Title:** 50 mg AMCC Fed
##### Group
**Description:** Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fasting State
**ID:** OG003
**Title:** 50 mg AMCC Fasting
##### Group
**Description:** Two, 25 mg Proellex capsules formulated with SMCC microcrystalline cellulose Fasting State
**ID:** OG004
**Title:** 50 mg SMCC Fasting
#### Outcome Measure 2
**Description:** Area under the plasma concentration curve from time 0 to the last measurable plasma concentration time point, up to 72 hours.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All 12 subjects received each treatment
**Reporting Status:** POSTED
**Time Frame:** Up to 72 hours post dose
**Title:** AUC0-last of Proellex
**Type:** PRIMARY
**Unit of Measure:** ng/mL*hour
##### Group
**Description:** 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fed State
**ID:** OG000
**Title:** 25 mg AMCC Fed
##### Group
**Description:** 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fasting State
**ID:** OG001
**Title:** 25 mg AMCC Fasting
##### Group
**Description:** Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fed State
**ID:** OG002
**Title:** 50 mg AMCC Fed
##### Group
**Description:** Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fasting State
**ID:** OG003
**Title:** 50 mg AMCC Fasting
##### Group
**Description:** Two, 25 mg Proellex capsules formulated with SMCC microcrystalline cellulose Fasting State
**ID:** OG004
**Title:** 50 mg SMCC Fasting
#### Outcome Measure 3
**Description:** Time to maximum plasma occurrence of Cmax
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All 12 subjects received each treatment
**Reporting Status:** POSTED
**Time Frame:** Up to 72 hours post dose
**Title:** Tmax of Proellex
**Type:** PRIMARY
**Unit of Measure:** Hours
##### Group
**Description:** 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fed State
**ID:** OG000
**Title:** 25 mg AMCC Fed
##### Group
**Description:** 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fasting State
**ID:** OG001
**Title:** 25 mg AMCC Fasting
##### Group
**Description:** Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fed State
**ID:** OG002
**Title:** 50 mg AMCC Fed
##### Group
**Description:** Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fasting State
**ID:** OG003
**Title:** 50 mg AMCC Fasting
##### Group
**Description:** Two, 25 mg Proellex capsules formulated with SMCC microcrystalline cellulose Fasting State
**ID:** OG004
**Title:** 50 mg SMCC Fasting
#### Outcome Measure 4
**Description:** 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
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All 12 subjects received each treatment
**Reporting Status:** POSTED
**Time Frame:** Up to 72 hours post dose
**Title:** AUC0-infinity of Proellex
**Type:** PRIMARY
**Unit of Measure:** ng/mL*hour
##### Group
**Description:** 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fed State
**ID:** OG000
**Title:** 25 mg AMCC Fed
##### Group
**Description:** 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fasting State
**ID:** OG001
**Title:** 25 mg AMCC Fasting
##### Group
**Description:** Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fed State
**ID:** OG002
**Title:** 50 mg AMCC Fed
##### Group
**Description:** Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fasting State
**ID:** OG003
**Title:** 50 mg AMCC Fasting
##### Group
**Description:** Two, 25 mg Proellex capsules formulated with SMCC microcrystalline cellulose Fasting State
**ID:** OG004
**Title:** 50 mg SMCC Fasting
#### Outcome Measure 5
**Description:** Time to maximum plasma occurrence of T1/2, calculated as ln(2)/Elimination rate constant.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All 12 subjects received each treatment
**Reporting Status:** POSTED
**Time Frame:** Up to 72 hours post dose
**Title:** Terminal Elimination Half-life (T1/2) of Proellex
**Type:** PRIMARY
**Unit of Measure:** Hours
##### Group
**Description:** 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fed State
**ID:** OG000
**Title:** 25 mg AMCC Fed
##### Group
**Description:** 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fasting State
**ID:** OG001
**Title:** 25 mg AMCC Fasting
##### Group
**Description:** Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fed State
**ID:** OG002
**Title:** 50 mg AMCC Fed
##### Group
**Description:** Two, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fasting State
**ID:** OG003
**Title:** 50 mg AMCC Fasting
##### Group
**Description:** Two, 25 mg Proellex capsules formulated with SMCC microcrystalline cellulose Fasting State
**ID:** OG004
**Title:** 50 mg SMCC Fasting
### Participant Flow Module
#### Group
**Description:** 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
**ID:** FG000
**Title:** Proellex
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 12
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 12
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Pre-Assignment Details:** Each of the 12 participants were randomly assigned a unique sequence of the following 5 following open-label treatments of Proellex

* 25 mg formulated with AMCC (fed state)
* 25 mg formulated with AMCC (fasting state)
* 50 mg formulated with AMCC (fed state)
* 50 mg formulated with AMCC (fasting state)
* 50 mg formulated with SMCC (fasting state)
**Recruitment Details:** 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.
**Has Results:** True