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Open-Label, Multiple-Dose, Non-Randomized Study to Assess Drug-Drug Interactions of Proellex® in Female Subjects

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ClinicalTrials.gov Identifier: NCT00741468
Recruitment Status : Completed
First Posted : August 26, 2008
Results First Posted : August 22, 2014
Last Update Posted : August 22, 2014
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Drug Interactions Drug: Proellex Drug: CYP1A2 probe Drug: CYP2C9 probe Drug: CYP2C19 probe Drug: CYP2D6 probe Drug: CYP3A4 probe Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: All subjects
Proellex 50 mg CYP1A2 probe CYP2C9 probe CYP2C19 probe CYP2D6 probe CYP3A4 probe
 Drug: Proellex
2, 25 mg Proellex capsules administered daily
Other Name: Telapristone acetate

Drug: CYP1A2 probe
Caffeine (200 mg)
Other Name: Caffeine (200 mg)

Drug: CYP2C9 probe
Tolbutamide (250 mg)
Other Name: Tolbutamide (250 mg)

Drug: CYP2C19 probe
Omeprazole (20 mg)
Other Name: Omeprazole (20 mg)

Drug: CYP2D6 probe
Dextromethorphan (30 mg)
Other Name: Dextromethorphan (30 mg)

Drug: CYP3A4 probe
Midazolam (2mg)
Other Name: Midazolam (2mg)


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult females
  • A body mass index between 18 and 30 kg/m2, inclusive
  • Negative urine drug and alcohol screen .

Exclusion Criteria:

  • Significant medical condition,
  • Significant physical examination finding
  • Clinical laboratory
  • ECG abnormality
  • CYP2D6 "poor metabolizer"
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00741468


Locations
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United States, New Jersey
Clinical Research Center Advanced Biomedical Research Inc.
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
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Study Director: Ronald Wiehle, PhD Repros Therapeutics Inc.
More Information
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Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00741468    
Other Study ID Numbers: ZP-007
First Posted: August 26, 2008    Key Record Dates
Results First Posted: August 22, 2014
Last Update Posted: August 22, 2014
Last Verified: August 2014
Keywords provided by Repros Therapeutics Inc.:
Drug-drug interactions
DDI
Additional relevant MeSH terms:
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Tolbutamide
Midazolam
Dextromethorphan
Caffeine
Omeprazole
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
 GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Antitussive Agents
Respiratory System Agents