HealthyPhase 1PKNCT00620503
Proellex® Pharmacokinetic Bridging Study II
A Phase 1 study testing Proellex 25 mg formulation A and Proellex 25 mg formulation B in people with Healthy, run by Repros Therapeutics Inc. at 1 site in United States.
Trial summary
An open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years. 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
- Healthy
- What is being tested?
- Proellex 25 mg formulation A and Proellex 25 mg formulation B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Feb 2008to 30 Apr 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 on an Institutional Review Board (IRB)-approved form prior to the initiation of any study procedures. Subject must have signed and dated a written Informed Consent Form (ICF) before undergoing any study related activities, including discontinuation of any prohibited medications
- 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
- In general good health
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- Must have agreed to not attempt to become pregnant at any time during study participation or for 30 days thereafter
- Must not have used tobacco (nicotine products) for at least two years before the study starts
- Must have normal (or abnormal and clinically insignificant) laboratory values at screening
- Willing to remain in the clinic for the screening visit and for the treatment visits
- Available for all treatment and follow-up visits
- Willing to comply with all study procedures
- Additional inclusion criteria may apply
Who cannot join
- Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study
- Past or present history of experiencing any allergic reaction to the formulations administered in this study, or in the opinion of the Principal Investigator, suggests an increased potential for an adverse hypersensitivity
- Any medical condition, which, in the judgment of the Principal Investigator, will prevent the subject from starting and/or completing the study
- Past or present history of any significant cardiovascular, renal, hepatic disease, thrombophlebitis, thromboembolic disorders, or cerebrovascular accident requiring ongoing medical therapy or clinical intervention
- A QTc interval of >450ms at screening
- Subject with abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Principal Investigator
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- Subjects with symptomatic uterine fibroids or endometriosis
- Use of other oral contraceptives or hormonal treatments within 30 days of first dose of study medication
- Use of a hormone-releasing intrauterine device
- Subject with a history of alcohol and/or drug abuse
- Known active infection of HIV, Hepatitis A, B or C
- Subject who has participated in a clinical trial with investigational medication within 30 days prior to study medication administration or who plans to take an experimental drug prior to the end of 30 days after participation in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthcare Discoveries Inc.
San Antonio, Texas, 78209
About this study
An open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years.
Read the detailed description
This is an open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years. Twelve female subjects will each receive a single dose of Proellex®: 25 mg (fed state, formulation A), 25 mg (fed state, formulation B), and 25 mg (fasting state, formulation B); successive dosing will be separated by at least one week intervals from the previous dosing. Blood will be collected prior to taking the dose, and following the dose for 24 hours post-dose. Subjects will be discharged from the study after the last blood sample is obtained after the third dose of Proellex®. Safety will be assessed throughout the study.
- Conditions
- Healthy
- Being tested
- Proellex 25 mg formulation A, Proellex 25 mg formulation B
- Keywords
- PK, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proellex 25 mg formulation ADrug
Also called Telapristonee acetate
One Proellex 25 mg formulation A capsule
Proellex 25 mg formulation BDrug
Also called Telapristone acetate
One 25 mg Proellex capsule formulation B administered both fed and fasted
| Study group | Role | What they receive |
|---|---|---|
| Formulation A Fed | Experimental | Single dose of Proellex 25 mg formulation A, fed Receives: Drug: Proellex 25 mg formulation A |
| Formulation B Fed | Experimental | Single dose of Proellex 25 mg formulation B, fed Receives: Drug: Proellex 25 mg formulation B |
| Formulation B Fasted | Experimental | Single dose of Proellex 25 mg formulation B, fasted Receives: Drug: Proellex 25 mg formulation B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Proellex
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
Measured: 24 hours
AUC0-last of Proellex
Area under the plasma concentration curve from time 0 (AUC0-last) to the last measurable plasma concentration time point, up to 24 hours.
Measured: Up to 24 hours
Tmax
Time to maximum plasma occurrence of Cmax
Measured: 24 hours
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: 24 hours
Terminal Elimination Half-life (T1/2) of Proellex
Time to maximum plasma occurrence of T1/2, calculated as ln(2)/Elimination rate constant.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study start29 Feb 2008
- Primary completion30 Apr 2008
- Study completion30 Apr 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 HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Chan, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620503
- Sponsor's protocol ID
- ZP-002
- Acronym
- PK
- Status last verified
- Jun 2019
- First submitted
- 4 Feb 2008
- Last updated
- 21 Jun 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 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proellex® Pharmacokinetic Bridging Study II
- ClinicalTrials.gov ID
- NCT00620503
- Acronym / sponsor ID
- PK / ZP-002
- Conditions
- Healthy
- Keywords
- PK, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Feb 2008 (actual)
- Primary completion
- 30 Apr 2008 (actual)
- Study completion
- 30 Apr 2008 (actual)
- First posted
- 21 Feb 2008 (estimated)
- Results
- Posted 21 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years.
Detailed description
This is an open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years. Twelve female subjects will each receive a single dose of Proellex®: 25 mg (fed state, formulation A), 25 mg (fed state, formulation B), and 25 mg (fasting state, formulation B); successive dosing will be separated by at least one week intervals from the previous dosing. Blood will be collected prior to taking the dose, and following the dose for 24 hours post-dose. Subjects will be discharged from the study after the last blood sample is obtained after the third dose of Proellex®. Safety will be assessed throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Formulation A Fed | Experimental | Drug: Proellex 25 mg formulation ASingle dose of Proellex 25 mg formulation A, fed |
| Formulation B Fed | Experimental | Drug: Proellex 25 mg formulation BSingle dose of Proellex 25 mg formulation B, fed |
| Formulation B Fasted | Experimental | Drug: Proellex 25 mg formulation BSingle dose of Proellex 25 mg formulation B, fasted |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subject must be able to speak, read and understand English and be willing and able to provide written informed consent on an Institutional Review Board (IRB)-approved form prior to the initiation of any study procedures. Subject must have signed and dated a written Informed Consent Form (ICF) before undergoing any study related activities, including discontinuation of any prohibited medications
- 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 (12 listed)
- Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study
- Past or present history of experiencing any allergic reaction to the formulations administered in this study, or in the opinion of the Principal Investigator, suggests an increased potential for an adverse hypersensitivity
- Any medical condition, which, in the judgment of the Principal Investigator, will prevent the subject from starting and/or completing the study
- Past or present history of any significant cardiovascular, renal, hepatic disease, thrombophlebitis, thromboembolic disorders, or cerebrovascular accident requiring ongoing medical therapy or clinical intervention
- A QTc interval of >450ms at screening
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 |
|---|---|---|
| Proellex 25 mg formulation AAlso: Telapristonee acetateOne Proellex 25 mg formulation A capsule | Drug | Formulation A Fed |
| Proellex 25 mg formulation BAlso: Telapristone acetateOne 25 mg Proellex capsule formulation B administered both fed and fasted | Drug | Formulation B Fasted, Formulation B Fed |
Primary outcome
Cmax of Proellex
Time frame: 24 hours
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
AUC0-last of Proellex
Time frame: Up to 24 hours
Area under the plasma concentration curve from time 0 (AUC0-last) to the last measurable plasma concentration time point, up to 24 hours.
Tmax
Time frame: 24 hours
Time to maximum plasma occurrence of Cmax
AUC0-infinity of Proellex
Time frame: 24 hours
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: 24 hours
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 21 Jun 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.
Anne 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 25 mg formulation A and Proellex 25 mg formulation B in people with Healthy, 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 13 inclusion and 12 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 21 Jun 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 21 Jun 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: 24 hours). 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 21 Jun 2019.