Drug InteractionsPhase 1NCT00741468
Open-Label, Multiple-Dose, Non-Randomized Study to Assess Drug-Drug Interactions of Proellex® in Female Subjects
A Phase 1 study testing Proellex, CYP1A2 probe and CYP2C9 probe in people with Drug Interactions, run by Repros Therapeutics Inc. at 1 site in United States.
Trial summary
This study will assess possible drug-drug interactions with specific isoenzymes over a total study duration of 6-8 weeks. Blood samples collected pre and post-dose, and urine samples collected post dose will be analyzed. 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
- Drug Interactions
- What is being tested?
- Proellex, CYP1A2 probe and CYP2C9 probe
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to 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 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult females
- A body mass index between 18 and 30 kg/m2, inclusive
- Negative urine drug and alcohol screen .
Who cannot join
- Significant medical condition,
- Significant physical examination finding
- Clinical laboratory
- ECG abnormality
- CYP2D6 "poor metabolizer"
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center Advanced Biomedical Research Inc.
Hackensack, New Jersey, 07601
About this study
Official title: An Open-Label, Multiple-Dose, Non-Randomized Study to Assess the Drug-Drug Interactions of Proellex® (CDB-4124) With Cytochrome P450 Isoenzymes CYP1A2, 2C9, 2C19, 2D6, and 3A4 in Healthy Female Subjects
This study will assess possible drug-drug interactions with specific isoenzymes over a total study duration of 6-8 weeks. Blood samples collected pre and post-dose, and urine samples collected post dose will be analyzed.
Read the detailed description
This is an open-label, multiple-dose, non-randomized study to assess the drug-drug interactions of Proellex® with cytochrome P450 isoenzymes in healthy female subjects. On Day 1, following an overnight fast and morning void of the bladder, subjects will be administered CYP probe drugs orally. Serial blood samples will be collected at pre-dose and post-dose. Subjects will be administered two Proellex® 25 mg capsules (50 mg total dose) at approximately 0800 hours on Day 2 and 0700 hours on Days 3 through 8. One hour after administration of Proellex® on Day 8, the five CYP probe drugs will be administered and blood and urine samples collected as on Day 1. Blood samples for the determination of plasma concentrations of CDB-4124 and its metabolite CDB-4453 will be collected at pre-dose (trough) on Days 6, 7, and 8 to determine if steady-state conditions have been achieved. Samples will also be collected on Day 8 at 1, 2, 8 and 24 hour after administration of Proellex® to determine the plasma concentrations of CDB-4124 and CDB-4453.
- Conditions
- Drug Interactions
- Being tested
- Proellex, CYP1A2 probe, CYP2C9 probe, CYP2C19 probe, CYP2D6 probe
- Keywords
- Drug-drug interactions, DDI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProellexDrug
Also called Telapristone acetate
2, 25 mg Proellex capsules administered daily
CYP1A2 probeDrug
Also called Caffeine (200 mg)
Caffeine (200 mg)
CYP2C9 probeDrug
Also called Tolbutamide (250 mg)
Tolbutamide (250 mg)
CYP2C19 probeDrug
Also called Omeprazole (20 mg)
Omeprazole (20 mg)
CYP2D6 probeDrug
Also called Dextromethorphan (30 mg)
Dextromethorphan (30 mg)
CYP3A4 probeDrug
Also called Midazolam (2mg)
Midazolam (2mg)
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | Proellex 50 mg CYP1A2 probe CYP2C9 probe CYP2C19 probe CYP2D6 probe CYP3A4 probe Receives: Drug: Proellex; Drug: CYP1A2 probe; Drug: CYP2C9 probe; Drug: CYP2C19 probe; Drug: CYP2D6 probe; Drug: CYP3A4 probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma AUC Ratio of Day 1 and Day 8
Assessment of the drug-drug interactions of Proellex® (CDB-4124) with cytochrome P450 isoenzymes CYP1A2, 2C9, 2C19, 2D6, and 3A4 in healthy female subjects administered 50 mg Proellex® once daily (QD). The Day 8 AUC was compared to the Day 1 AUC to determine inhibition.
For CYP1A2 the plasma paraxanthine/caffeine MR ratio (metabolic ratio) was used. For CYP2D6 the MR ratio of dextromethorphan/dextrorphan was used.
Measured: 8 days
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 startJul 2008
- Primary completionSep 2008
- Study completionOct 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 Drug InteractionsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald Wiehle, PhD, Study director, Repros Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741468
- Sponsor's protocol ID
- ZP-007
- Status last verified
- Aug 2014
- First submitted
- 25 Aug 2008
- Last updated
- 22 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 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multiple-Dose, Non-Randomized Study to Assess the Drug-Drug Interactions of Proellex® (CDB-4124) With Cytochrome P450 Isoenzymes CYP1A2, 2C9, 2C19, 2D6, and 3A4 in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT00741468
- Acronym / sponsor ID
- ZP-007
- Conditions
- Drug Interactions
- Keywords
- Drug-drug interactions, DDI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 26 Aug 2008 (estimated)
- Results
- Posted 22 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 assess possible drug-drug interactions with specific isoenzymes over a total study duration of 6-8 weeks. Blood samples collected pre and post-dose, and urine samples collected post dose will be analyzed.
Detailed description
This is an open-label, multiple-dose, non-randomized study to assess the drug-drug interactions of Proellex® with cytochrome P450 isoenzymes in healthy female subjects. On Day 1, following an overnight fast and morning void of the bladder, subjects will be administered CYP probe drugs orally. Serial blood samples will be collected at pre-dose and post-dose. Subjects will be administered two Proellex® 25 mg capsules (50 mg total dose) at approximately 0800 hours on Day 2 and 0700 hours on Days 3 through 8. One hour after administration of Proellex® on Day 8, the five CYP probe drugs will be administered and blood and urine samples collected as on Day 1. Blood samples for the determination of plasma concentrations of CDB-4124 and its metabolite CDB-4453 will be collected at pre-dose (trough) on Days 6, 7, and 8 to determine if steady-state conditions have been achieved. Samples will also be collected on Day 8 at 1, 2, 8 and 24 hour after administration of Proellex® to determine the plasma concentrations of CDB-4124 and CDB-4453.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Drug: Proellex, Drug: CYP1A2 probe, Drug: CYP2C9 probe, Drug: CYP2C19 probe, Drug: CYP2D6 probe, Drug: CYP3A4 probeProellex 50 mg CYP1A2 probe CYP2C9 probe CYP2C19 probe CYP2D6 probe CYP3A4 probe |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult females
- A body mass index between 18 and 30 kg/m2, inclusive
- Negative urine drug and alcohol screen .
Key exclusion criteria (5 listed)
- Significant medical condition,
- Significant physical examination finding
- Clinical laboratory
- ECG abnormality
- CYP2D6 "poor metabolizer"
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 acetate2, 25 mg Proellex capsules administered daily | Drug | All subjects |
| CYP1A2 probeAlso: Caffeine (200 mg)Caffeine (200 mg) | Drug | All subjects |
| CYP2C9 probeAlso: Tolbutamide (250 mg)Tolbutamide (250 mg) | Drug | All subjects |
| CYP2C19 probeAlso: Omeprazole (20 mg)Omeprazole (20 mg) | Drug | All subjects |
| CYP2D6 probeAlso: Dextromethorphan (30 mg)Dextromethorphan (30 mg) | Drug | All subjects |
| CYP3A4 probeAlso: Midazolam (2mg)Midazolam (2mg) | Drug | All subjects |
Primary outcome
Plasma AUC Ratio of Day 1 and Day 8
Time frame: 8 days
Assessment of the drug-drug interactions of Proellex® (CDB-4124) with cytochrome P450 isoenzymes CYP1A2, 2C9, 2C19, 2D6, and 3A4 in healthy female subjects administered 50 mg Proellex® once daily (QD). The Day 8 AUC was compared to the Day 1 AUC to determine inhibition. For CYP1A2 the plasma paraxanthine/caffeine MR ratio (metabolic ratio) was used. For CYP2D6 the MR ratio of dextromethorphan/dextrorphan was used.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 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.
Ronald Wiehle, PhD study director
Repros Therapeutics Inc.
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, CYP1A2 probe and CYP2C9 probe in people with Drug Interactions, 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 3 inclusion and 5 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 22 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 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 22 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?
Plasma AUC Ratio of Day 1 and Day 8 (time frame: 8 days). 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 22 Aug 2014.