Trial Outcomes & Findings for Proellex® Pharmacokinetic Bridging Study II (NCT NCT00620503)
NCT ID: NCT00620503
Last Updated: 2019-06-21
Results Overview
Maximum observed concentration (Cmax) of a single dose of Proellex® (25 mg) Formulation A using two different formulations of the drug in healthy adult female subjects with or without fasting
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
24 hours
Results posted on
2019-06-21
Participant Flow
Participant milestones
| Measure |
TP1: Fed A, TP2: Fasting B, TP3:Fed B
Three different treatments of Proellex 25 mg, given in a randomized treatment sequence.
* Proellex 25 mg capsule, Formulation A, fed state.
* Proellex 25 mg Formulation B, fed state.
* Proellex 25 mg Formulation B, fasting state.
|
TP1: Fed B, TP2: Fed A, TP3: Fasting B
Three different treatments of Proellex 25 mg, given in a randomized treatment sequence.
* Proellex 25 mg capsule, Formulation A, fed state.
* Proellex 25 mg Formulation B, fed state.
* Proellex 25 mg Formulation B, fasting state.
|
TP1: Fasting B, TP2: Fed B, TP3: Fed A
Three different treatments of Proellex 25 mg, given in a randomized treatment sequence.
* Proellex 25 mg capsule, Formulation A, fed state.
* Proellex 25 mg Formulation B, fed state.
* Proellex 25 mg Formulation B, fasting state.
|
TP1: Fed A, TP2: Fed B, TP3: Fasting B
Three different treatments of Proellex 25 mg, given in a randomized treatment sequence.
* Proellex 25 mg capsule, Formulation A, fed state.
* Proellex 25 mg Formulation B, fed state.
* Proellex 25 mg Formulation B, fasting state.
|
TP1: Fasting B, TP2: Fed A, TP3: Fed B
Three different treatments of Proellex 25 mg, given in a randomized treatment sequence.
* Proellex 25 mg capsule, Formulation A, fed state.
* Proellex 25 mg Formulation B, fed state.
* Proellex 25 mg Formulation B, fasting state.
|
TP1: Fed B, TP2: Fasting B, TP3: Fed A
Three different treatments of Proellex 25 mg, given in a randomized treatment sequence.
* Proellex 25 mg capsule, Formulation A, fed state.
* Proellex 25 mg Formulation B, fed state.
* Proellex 25 mg Formulation B, fasting state.
|
|---|---|---|---|---|---|---|
|
Screening (up to 21 Days)
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Screening (up to 21 Days)
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Screening (up to 21 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 1 (TP1) (7days)
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Treatment Period 1 (TP1) (7days)
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Treatment Period 1 (TP1) (7days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout (at Least 1 Day)
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Washout (at Least 1 Day)
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Washout (at Least 1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (TP2) (7days)
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Treatment Period 2 (TP2) (7days)
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Treatment Period 2 (TP2) (7days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3 (TP3) (7 Days)
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Treatment Period 3 (TP3) (7 Days)
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Treatment Period 3 (TP3) (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Follow-up (up to 14 Days)
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Follow-up (up to 14 Days)
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Follow-up (up to 14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Proellex® Pharmacokinetic Bridging Study II
Baseline characteristics by cohort
| Measure |
25 mg Proellex
n=12 Participants
Three different treatments of Proellex 25 mg, given in a randomized treatment sequence.
* Proellex 25 mg capsule, Formulation A, fed state.
* Proellex 25 mg Formulation B, fed state.
* Proellex 25 mg Formulation B, fasting state.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursMaximum observed concentration (Cmax) of a single dose of Proellex® (25 mg) Formulation A using two different formulations of the drug in healthy adult female subjects with or without fasting
Outcome measures
| Measure |
Formulation A Fed
n=12 Participants
Single dose of Proellex 25 mg formulation A, fed
|
Formulation B Fed
n=12 Participants
Single dose of Proellex 25 mg formulation B, fed
|
Formulation B Fasted
n=12 Participants
Single dose of Proellex 25 mg formulation B, fasted
|
|---|---|---|---|
|
Cmax of Proellex
|
405.5 ng/mL
Standard Deviation 168.2
|
426.7 ng/mL
Standard Deviation 158.0
|
824.2 ng/mL
Standard Deviation 351.7
|
PRIMARY outcome
Timeframe: Up to 24 hoursPopulation: ITT and Safety populations are the same
Area under the plasma concentration curve from time 0 (AUC0-last) to the last measurable plasma concentration time point, up to 24 hours.
Outcome measures
| Measure |
Formulation A Fed
n=12 Participants
Single dose of Proellex 25 mg formulation A, fed
|
Formulation B Fed
n=12 Participants
Single dose of Proellex 25 mg formulation B, fed
|
Formulation B Fasted
n=12 Participants
Single dose of Proellex 25 mg formulation B, fasted
|
|---|---|---|---|
|
AUC0-last of Proellex
|
6851.5 ng/mL*hour
Standard Deviation 5686.2
|
7967.9 ng/mL*hour
Standard Deviation 7125.9
|
6161.8 ng/mL*hour
Standard Deviation 4364.5
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: All 12 participants in the Safety population are included in the Intent-to-Treat (ITT) population.
Time to maximum plasma occurrence of Cmax
Outcome measures
| Measure |
Formulation A Fed
n=12 Participants
Single dose of Proellex 25 mg formulation A, fed
|
Formulation B Fed
n=12 Participants
Single dose of Proellex 25 mg formulation B, fed
|
Formulation B Fasted
n=12 Participants
Single dose of Proellex 25 mg formulation B, fasted
|
|---|---|---|---|
|
Tmax
|
3.1 Hours
Standard Deviation 1.2
|
2.9 Hours
Standard Deviation 1.2
|
1.0 Hours
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: All 12 participants in the Safety population are included in the Intent-to-Treat (ITT) population.
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
Outcome measures
| Measure |
Formulation A Fed
n=12 Participants
Single dose of Proellex 25 mg formulation A, fed
|
Formulation B Fed
n=12 Participants
Single dose of Proellex 25 mg formulation B, fed
|
Formulation B Fasted
n=12 Participants
Single dose of Proellex 25 mg formulation B, fasted
|
|---|---|---|---|
|
AUC0-infinity of Proellex
|
6851.5 ng/mL*hour
Standard Deviation 5686.2
|
7967.9 ng/mL*hour
Standard Deviation 7125.9
|
6554.0 ng/mL*hour
Standard Deviation 4350.1
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: All 12 participants in the Safety population are included in the Intent-to-Treat (ITT) population.
Time to maximum plasma occurrence of T1/2, calculated as ln(2)/Elimination rate constant.
Outcome measures
| Measure |
Formulation A Fed
n=12 Participants
Single dose of Proellex 25 mg formulation A, fed
|
Formulation B Fed
n=12 Participants
Single dose of Proellex 25 mg formulation B, fed
|
Formulation B Fasted
n=12 Participants
Single dose of Proellex 25 mg formulation B, fasted
|
|---|---|---|---|
|
Terminal Elimination Half-life (T1/2) of Proellex
|
23.2 Hours
Standard Deviation 14.8
|
27.3 Hours
Standard Deviation 20.7
|
19.2 Hours
Standard Deviation 9.0
|
Adverse Events
Single Dose of Proellex 25 mg Formulation A, Fed
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Single Dose of Proellex 25 mg Formulation B, Fed
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Single Dose of Proellex 25 mg Formulation B, Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Dose of Proellex 25 mg Formulation A, Fed
n=12 participants at risk
Formulation A: One Proellex 25 mg formulation A capsule, Fed
|
Single Dose of Proellex 25 mg Formulation B, Fed
n=12 participants at risk
formulation B: One 25 mg Proellex capsule formulation B administered both fed and fasted.
|
Single Dose of Proellex 25 mg Formulation B, Fasted
n=12 participants at risk
Formulation B: One 25 mg Proellex capsule formulation B administered both fed and fasted
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
|
Gastrointestinal disorders
GI cramps
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Nervous system disorders
Headache
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Psychiatric disorders
Emotional lability
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
|
Reproductive system and breast disorders
Menstruation increased
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
Additional Information
Therapeutic Area Head
Repros Therapeutics Inc, an Allergan Affiliate
Phone: 714-246-4500
Email: [email protected]
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