Impaired Liver FunctionPhase 1NCT00741273
Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults
A Phase 1 study testing Proellex in people with Impaired Liver Function, run by Repros Therapeutics Inc. at 2 sites in United States.
Trial summary
This study will evaluate the safety and pharmacokinetics of two doses of orally administered Proellex® in female patients with impaired hepatic function and healthy volunteers with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 62 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Impaired Liver Function
- 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
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2008to Jun 2009
- 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 62 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, are preferred; however, subjects up to 62 years old, inclusive, may participate;
- Subjects with moderate hepatic insufficiency must meet the Class B level of the Child-Pugh criteria;
- Subjects must have evidence of stable hepatic impairment;
- If on medications for treatment of the complications of liver disease, and other concomitant chronic illnesses, subjects must have been taking the medications at a stable dose for at least 10 days prior to the first dosing date and are then to be continued at the same dose for the duration of the study;
- Non-smokers are preferred, but light to moderate smoking will be allowed (no more than 10 cigarettes/day)
- Subject is willing to remain in the clinic for the screening visit and for two treatment visits (approximately 3 days for each treatment visit);
- Other inclusion criteria may apply
Who cannot join
- Past or present history of an allergic reaction to the formulations administered in this study, or in the opinion of the Investigator, suggesting an increased potential for an adverse hypersensitivity;
- 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;
- A physical illness within three (3) months of the study that would interfere with the study as determined by the Investigator;
- An acute illness within five (5) days of study medication administration;
- Positive urine drug screen at the screening visit based on laboratory testing;
- Other exclusion criteria may apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Pharmacology of Miami, Inc.
Miami, Florida, 33014-3616
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: An Open-label, Two-stage, Dose-escalation, Parallel Group Study to Evaluate the Safety and Pharmacokinetics Profile of Proellex® (CDB-4124) in Female Patients With Impaired Hepatic Function and Healthy Adult Volunteers
This study will evaluate the safety and pharmacokinetics of two doses of orally administered Proellex® in female patients with impaired hepatic function and healthy volunteers with normal hepatic function.
Read the detailed description
16 subjects will be allocated to 2 groups. The test group will consist of 8 female patients with moderately impaired hepatic function meeting the Child-Pugh Class B severity criteria, while the control group will consist of 8 healthy female adult volunteers. During Stage I, all subjects will receive a single oral dose of 25mg of Proellex® (fasting state) and be followed in a Clinical Research Unit (CRU) for about three days. Only subjects who do not experience serious adverse events (SAEs) or adverse events (AEs) that are determined by Investigator to be possibly, probably or definitely related to the treatment will participate in Stage II. The dose will be increased to a single dose of 50mg of Proellex® (fasting state) and subjects will be followed in a Clinical Research Unit (CRU) for about three days. Subjects will undergo blood draws at several time points.
- Conditions
- Impaired Liver Function
- Being tested
- Proellex
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProellexDrug
Also called Telapristone acetate
Proellex 25 mg capsule, single dose
| Study group | Role | What they receive |
|---|---|---|
| Proellex 25 mg healthy | Experimental | Proellex 25 mg in healthy females Receives: Drug: Proellex |
| Proellex 25 mg Impaired | Experimental | Proellex 50 mg in hepatically impaired females Receives: Drug: Proellex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Blood Concentration (Cmax)
Cmax of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function, assessed from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose..
Measured: 48 hours
Proellex Half-life (T1/2)
Time for Proellex concentration to decrease by half (T1/2) of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function,measured from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose..
Measured: 48 hours
Secondary outcomes (1)
Area Under the Curve (AUC0-t) for Proellex
AUC0-t of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function, measured from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose.
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 posted26 Aug 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2009
- Study completionJun 2009
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 Impaired Liver FunctionStudies 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT00741273
- Sponsor's protocol ID
- ZP-005
- Status last verified
- Aug 2014
- First submitted
- 25 Aug 2008
- Last updated
- 28 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 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Two-stage, Dose-escalation, Parallel Group Study to Evaluate the Safety and Pharmacokinetics Profile of Proellex® (CDB-4124) in Female Patients With Impaired Hepatic Function and Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT00741273
- Acronym / sponsor ID
- ZP-005
- Conditions
- Impaired Liver Function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 26 Aug 2008 (estimated)
- Results
- Posted 28 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and pharmacokinetics of two doses of orally administered Proellex® in female patients with impaired hepatic function and healthy volunteers with normal hepatic function.
Detailed description
16 subjects will be allocated to 2 groups. The test group will consist of 8 female patients with moderately impaired hepatic function meeting the Child-Pugh Class B severity criteria, while the control group will consist of 8 healthy female adult volunteers. During Stage I, all subjects will receive a single oral dose of 25mg of Proellex® (fasting state) and be followed in a Clinical Research Unit (CRU) for about three days. Only subjects who do not experience serious adverse events (SAEs) or adverse events (AEs) that are determined by Investigator to be possibly, probably or definitely related to the treatment will participate in Stage II. The dose will be increased to a single dose of 50mg of Proellex® (fasting state) and subjects will be followed in a Clinical Research Unit (CRU) for about three days. Subjects will undergo blood draws at several time points.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proellex 25 mg healthy | Experimental | Drug: ProellexProellex 25 mg in healthy females |
| Proellex 25 mg Impaired | Experimental | Drug: ProellexProellex 50 mg in hepatically impaired females |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 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, are preferred; however, subjects up to 62 years old, inclusive, may participate;
- Subjects with moderate hepatic insufficiency must meet the Class B level of the Child-Pugh criteria;
- Subjects must have evidence of stable hepatic impairment;
- If on medications for treatment of the complications of liver disease, and other concomitant chronic illnesses, subjects must have been taking the medications at a stable dose for at least 10 days prior to the first dosing date and are then to be continued at the same dose for the duration of the study;
Key exclusion criteria (6 listed)
- Past or present history of an allergic reaction to the formulations administered in this study, or in the opinion of the Investigator, suggesting an increased potential for an adverse hypersensitivity;
- 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;
- A physical illness within three (3) months of the study that would interfere with the study as determined by the Investigator;
- An acute illness within five (5) days of study medication administration;
- Positive urine drug screen at the screening visit based on laboratory testing;
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 acetateProellex 25 mg capsule, single dose | Drug | Proellex 25 mg Impaired, Proellex 25 mg healthy |
Primary outcome
Maximum Blood Concentration (Cmax)
Time frame: 48 hours
Cmax of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function, assessed from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose..
Proellex Half-life (T1/2)
Time frame: 48 hours
Time for Proellex concentration to decrease by half (T1/2) of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function,measured from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose..
1 secondary outcome
Area Under the Curve (AUC0-t) for 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 28 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Hepatic Impairment
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.
2 sites 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 Impaired Liver Function, run by Repros Therapeutics Inc. at 2 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 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 28 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 2 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 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 28 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?
Maximum Blood Concentration (Cmax) (time frame: 48 hours). The study lists 2 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 28 Aug 2014.