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

NCT ID: NCT00741468

Last Updated: 2014-08-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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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

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Drug Interactions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All subjects

Proellex 50 mg CYP1A2 probe CYP2C9 probe CYP2C19 probe CYP2D6 probe CYP3A4 probe

Group Type EXPERIMENTAL

Proellex

Intervention Type DRUG

2, 25 mg Proellex capsules administered daily

CYP1A2 probe

Intervention Type DRUG

Caffeine (200 mg)

CYP2C9 probe

Intervention Type DRUG

Tolbutamide (250 mg)

CYP2C19 probe

Intervention Type DRUG

Omeprazole (20 mg)

CYP2D6 probe

Intervention Type DRUG

Dextromethorphan (30 mg)

CYP3A4 probe

Intervention Type DRUG

Midazolam (2mg)

Interventions

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Proellex

2, 25 mg Proellex capsules administered daily

Intervention Type DRUG

CYP1A2 probe

Caffeine (200 mg)

Intervention Type DRUG

CYP2C9 probe

Tolbutamide (250 mg)

Intervention Type DRUG

CYP2C19 probe

Omeprazole (20 mg)

Intervention Type DRUG

CYP2D6 probe

Dextromethorphan (30 mg)

Intervention Type DRUG

CYP3A4 probe

Midazolam (2mg)

Intervention Type DRUG

Other Intervention Names

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Telapristone acetate Caffeine (200 mg) Tolbutamide (250 mg) Omeprazole (20 mg) Dextromethorphan (30 mg) Midazolam (2mg)

Eligibility Criteria

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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"
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Repros Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald Wiehle, PhD

Role: STUDY_DIRECTOR

Repros Therapeutics Inc.

Locations

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Clinical Research Center Advanced Biomedical Research Inc.

Hackensack, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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ZP-007

Identifier Type: -

Identifier Source: org_study_id

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