Trial Outcomes & Findings for A Safety and Pharmacokinetic Study of Proellex® (NCT NCT00619385)
NCT ID: NCT00619385
Last Updated: 2014-08-08
Results Overview
To determine the safety and PK properties of 100 mg, 150 mg and 200 mg of Proellex® taken for seven days by healthy adult female subjects.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
7 days
Results posted on
2014-08-08
Participant Flow
Participant milestones
| Measure |
Proellex 100 mg
Proellex 100 mg daily for 7 days
|
Proellex 150 mg
Proellex 150 mg daily for 7 days
|
Proellex 200 mg
Proellex 200 mg daily for 7 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
10
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
4
|
Reasons for withdrawal
| Measure |
Proellex 100 mg
Proellex 100 mg daily for 7 days
|
Proellex 150 mg
Proellex 150 mg daily for 7 days
|
Proellex 200 mg
Proellex 200 mg daily for 7 days
|
|---|---|---|---|
|
Overall Study
Other
|
1
|
2
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
3
|
Baseline Characteristics
A Safety and Pharmacokinetic Study of Proellex®
Baseline characteristics by cohort
| Measure |
Proellex 100 mg
n=7 Participants
Proellex 100 mg daily for 7 days
Proellex: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days
|
Proellex 150 mg
n=8 Participants
Proellex 150 mg daily for 7 days
Proellex: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days
|
Proellex 200 mg
n=10 Participants
Proellex 200 mg daily for 7 days
Proellex: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
10 participants
n=5 Participants
|
25 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7 daysTo determine the safety and PK properties of 100 mg, 150 mg and 200 mg of Proellex® taken for seven days by healthy adult female subjects.
Outcome measures
| Measure |
Proellex 100 mg
n=6 Participants
Proellex 100 mg daily for 7 days
|
Proellex 150 mg
n=6 Participants
Proellex 150 mg daily for 7 days
|
Proellex 200 mg Caps
n=3 Participants
Proellex 200 mg daily for 7 days capsules
|
Proellex 200 mg Vials
n=3 Participants
Proellex 200 mg daily for 7 days vials
|
|---|---|---|---|---|
|
Cmax Post Final Dose
|
1944 ng/mL
Standard Deviation 625
|
3807 ng/mL
Standard Deviation 1670
|
2293 ng/mL
Standard Deviation 1319
|
2777 ng/mL
Standard Deviation 954
|
PRIMARY outcome
Timeframe: 7 daysOutcome measures
| Measure |
Proellex 100 mg
n=6 Participants
Proellex 100 mg daily for 7 days
|
Proellex 150 mg
n=6 Participants
Proellex 150 mg daily for 7 days
|
Proellex 200 mg Caps
n=3 Participants
Proellex 200 mg daily for 7 days capsules
|
Proellex 200 mg Vials
n=3 Participants
Proellex 200 mg daily for 7 days vials
|
|---|---|---|---|---|
|
AUC Post Final Dose
|
57591 hour*ng/mL
Standard Deviation 70514
|
137634 hour*ng/mL
Standard Deviation 146024
|
230731 hour*ng/mL
Standard Deviation 371463
|
190324 hour*ng/mL
Standard Deviation 95387
|
Adverse Events
Proellex 100 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Proellex 150 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Proellex 200 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Proellex 100 mg
n=7 participants at risk
Proellex 100 mg daily for 7 days
|
Proellex 150 mg
n=8 participants at risk
Proellex 150 mg daily for 7 days
|
Proellex 200 mg
n=10 participants at risk
Proellex 200 mg daily for 7 days
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
|
Eye disorders
Vision blurred
|
0.00%
0/7
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7
|
0.00%
0/8
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
30.0%
3/10 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7
|
0.00%
0/8
|
50.0%
5/10 • Number of events 5
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/7
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/7
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Pyrexia
|
0.00%
0/7
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
UTI
|
0.00%
0/7
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Sunburn
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
|
Investigations
Transaminases increased
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
|
Nervous system disorders
Dizziness
|
28.6%
2/7 • Number of events 2
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/10
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • Number of events 2
|
0.00%
0/8
|
50.0%
5/10 • Number of events 5
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/7
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/7
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Polyuria
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
|
Renal and urinary disorders
Pyuria
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Reproductive system and breast disorders
Amenorrhea
|
0.00%
0/7
|
0.00%
0/8
|
20.0%
2/10 • Number of events 2
|
|
Reproductive system and breast disorders
Oligomenorrhea
|
42.9%
3/7 • Number of events 3
|
37.5%
3/8 • Number of events 3
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/7
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/7
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER