PharmacokineticsPhase 1NCT00749879
Crossover Study of the Safety and PK Properties of Proellex®
A Phase 1 study testing Proellex in people with Pharmacokinetics, run by Repros Therapeutics Inc. at 1 site in United States.
Trial summary
Study to evaluate the PK of 25 mg and 50 mg of Proellex from 2 different suppliers in the fed and fasting states. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Proellex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2008to 23 Oct 2008
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthcare Discoveries Inc.
San Antonio, Texas, 78229
About this study
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®
Study to evaluate the PK of 25 mg and 50 mg of Proellex from 2 different suppliers in the fed and fasting states.
Read the 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
- Pharmacokinetics
- Being tested
- Proellex
- Keywords
- PK, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProellexDrug
Also called Telapristone acetate
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
| Study group | Role | What they receive |
|---|---|---|
| 25 mg AMCC fed | Experimental | 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose
Fed State Receives: Drug: Proellex |
| 25 mg AMCC fasting | Experimental | 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose
Fasting State Receives: Drug: Proellex |
| 50 mg AMCC fed | Experimental | 2, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose
Fed State Receives: Drug: Proellex |
| 50 mg AMCC fasting | Experimental | 2, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose
Fasting State Receives: Drug: Proellex |
| 50 mg SMCC fasting | Experimental | 2, 25 mg Proellex capsules formulated with SMCC microcrystalline cellulose
Fasting State Receives: Drug: Proellex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Proellex
Maximum observed concentration of Proellex
Measured: 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.
Measured: Up to 72 hours post dose
Tmax of Proellex
Time to maximum plasma occurrence of Cmax
Measured: 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
Measured: 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.
Measured: Up to 72 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study start11 Aug 2008
- Primary completion23 Oct 2008
- Study completion23 Oct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Chan, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749879
- Sponsor's protocol ID
- ZP-008
- Status last verified
- Jan 2019
- First submitted
- 5 Sep 2008
- Last updated
- 29 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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®
- ClinicalTrials.gov ID
- NCT00749879
- Acronym / sponsor ID
- ZP-008
- Conditions
- Pharmacokinetics
- Keywords
- PK, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2008 (actual)
- Primary completion
- 23 Oct 2008 (actual)
- Study completion
- 23 Oct 2008 (actual)
- First posted
- 9 Sep 2008 (estimated)
- Results
- Posted 29 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 25 mg AMCC fed | Experimental | Drug: Proellex25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fed State |
| 25 mg AMCC fasting | Experimental | Drug: Proellex25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fasting State |
| 50 mg AMCC fed | Experimental | Drug: Proellex2, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fed State |
| 50 mg AMCC fasting | Experimental | Drug: Proellex2, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fasting State |
| 50 mg SMCC fasting | Experimental | Drug: Proellex2, 25 mg Proellex capsules formulated with SMCC microcrystalline cellulose Fasting State |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProellexAlso: Telapristone acetate25 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 | Drug | 25 mg AMCC fasting, 25 mg AMCC fed, 50 mg AMCC fasting, 50 mg AMCC fed, 50 mg SMCC fasting |
Primary outcome
Cmax of Proellex
Time frame: Up to 72 hours post-dose
Maximum observed concentration of Proellex
AUC0-last of Proellex
Time frame: Up to 72 hours post dose
Area under the plasma concentration curve from time 0 to the last measurable plasma concentration time point, up to 72 hours.
Tmax of Proellex
Time frame: Up to 72 hours post dose
Time to maximum plasma occurrence of Cmax
AUC0-infinity of Proellex
Time frame: Up to 72 hours post dose
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
Terminal Elimination Half-life (T1/2) of Proellex
Time frame: Up to 72 hours post dose
Time to maximum plasma occurrence of T1/2, calculated as ln(2)/Elimination rate constant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Chan study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Proellex in people with Pharmacokinetics, run by Repros Therapeutics Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of Proellex (time frame: Up to 72 hours post-dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.