Renal ImpairmentPhase 1/2NCT00787618
Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females
A Phase 1/2 study testing 50 mg Proellex in people with Renal Impairment, run by Repros Therapeutics Inc. at 4 sites in United States.
Trial summary
PK and safety profile of Proellex® in females with various stages of impaired renal function Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- 50 mg Proellex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2008to Jul 2009
- Phase
- Phase 1/2
- 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 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
- Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive, is preferred
- Subject must meet the criteria of mildly or moderately impaired renal function or have normal renal function
- Subject with renal impairment must have evidence of stable disease
- If on medications for treatment of the complications of renal disease, and other concommitant chronic illnesses, subject must have been taking the medications at a stable dose for at least 10 days prior to the first Proellex® dosing date and are then to be continued at the same dose for the duration of the study.
- Negative urine pregnancy test at screening visit
Show all 10Show fewer
- Subject must agree to use a medically acceptable and effective non-hormonal double barrier method of birth control
- Healthy subject must have no significant abnormal findings at the screening physical examination
- Subject is willing to remain in the clinic for the screening visit (approximately 1 day for the first screening visit) and for the treatment visit (approximately 3 days)
- Additional inclusion criteria may apply
Who cannot join
- Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant
- Subject with clinically significant abnormal liver function
- Pregnant or lactating females, or women who are attempting or expecting to become pregnant at any time during the study or one month after the study
- An acute illness within five (5) days of study medication administration
- Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system
- Additional exclusion criteria may apply
Trial locations and contacts
4 sites in 1 country.
United States4 sites
New Orleans Center for Clinical Research - Knoxville
Knoxville, Tennessee, 37920
Clinical Pharmacology of Miami, Inc
Miami, Florida, 33014-3616
DaVita Clinical Research
Minneapolis, Minnesota, 55404
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: A Single-Dose, Open-Label, Parallel Group Study To Evaluate The Pharmacokinetics And Safety Profile Of PROELLEX® (CDB-4124) In Female Subjects With Various Stages Of Impaired Renal Function And In Healthy Female Volunteers
PK and safety profile of Proellex® in females with various stages of impaired renal function
Read the detailed description
The study will evaluate the pharmacokinetics and safety profile of Proellex® in females with various stages of impaired renal function and in volunteers with normal renal function
- Conditions
- Renal Impairment
- Being tested
- 50 mg Proellex
- Keywords
- Renal impairment
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 mg ProellexDrug
Also called Telapristone acetate, Proellex
Single dose
| Study group | Role | What they receive |
|---|---|---|
| 50 mg Proellex Mild impairment | Active comparator | 50 mg Proellex single dose Female subjects with mild renal impairment function. Receives: Drug: 50 mg Proellex |
| 50 mg Proellex Moderate | Active comparator | 50 mg Proellex, Female subjects with moderate renal impairment function. Receives: Drug: 50 mg Proellex |
| 50 mg Proellex, Normal | Active comparator | 50 mg Proellex, Female subjects with normal renal function. Receives: Drug: 50 mg Proellex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Proellex
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionJul 2009
Why it stopped: Increased LFTs
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 Renal ImpairmentStudies 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 1/2
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andre van As, MD, PhD, Study director, Repros Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787618
- Sponsor's protocol ID
- ZP-006
- Status last verified
- Aug 2014
- First submitted
- 6 Nov 2008
- Last updated
- 25 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Parallel Group Study To Evaluate The Pharmacokinetics And Safety Profile Of PROELLEX® (CDB-4124) In Female Subjects With Various Stages Of Impaired Renal Function And In Healthy Female Volunteers
- ClinicalTrials.gov ID
- NCT00787618
- Acronym / sponsor ID
- ZP-006
- Conditions
- Renal Impairment
- Keywords
- Renal impairment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Increased LFTs
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 7 Nov 2008 (estimated)
- Results
- Posted 25 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PK and safety profile of Proellex® in females with various stages of impaired renal function
Detailed description
The study will evaluate the pharmacokinetics and safety profile of Proellex® in females with various stages of impaired renal function and in volunteers with normal renal function
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 50 mg Proellex Mild impairment | Active comparator | Drug: 50 mg Proellex50 mg Proellex single dose Female subjects with mild renal impairment function. |
| 50 mg Proellex Moderate | Active comparator | Drug: 50 mg Proellex50 mg Proellex, Female subjects with moderate renal impairment function. |
| 50 mg Proellex, Normal | Active comparator | Drug: 50 mg Proellex50 mg Proellex, Female subjects with normal renal function. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
- Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive, is preferred
- Subject must meet the criteria of mildly or moderately impaired renal function or have normal renal function
- Subject with renal impairment must have evidence of stable disease
- If on medications for treatment of the complications of renal disease, and other concommitant chronic illnesses, subject must have been taking the medications at a stable dose for at least 10 days prior to the first Proellex® dosing date and are then to be continued at the same dose for the duration of the study.
Key exclusion criteria (6 listed)
- Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant
- Subject with clinically significant abnormal liver function
- Pregnant or lactating females, or women who are attempting or expecting to become pregnant at any time during the study or one month after the study
- An acute illness within five (5) days of study medication administration
- Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system
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 |
|---|---|---|
| 50 mg ProellexAlso: Telapristone acetate, ProellexSingle dose | Drug | 50 mg Proellex Mild impairment, 50 mg Proellex Moderate, 50 mg Proellex, Normal |
Primary outcome
Cmax of Proellex
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2014.
- 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.
Andre van As, MD, PhD study director
Repros Therapeutics Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 50 mg Proellex in people with Renal Impairment, run by Repros Therapeutics Inc. at 4 sites 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 10 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: stopped early, as of the sponsor's last update on 25 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 25 Aug 2014). 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: 48 hours). 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 25 Aug 2014.