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
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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 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: All subjects
Proellex 50 mg CYP1A2 probe CYP2C9 probe CYP2C19 probe CYP2D6 probe CYP3A4 probe
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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) |
- 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.

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

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
United States, New Jersey | |
Clinical Research Center Advanced Biomedical Research Inc. | |
Hackensack, New Jersey, United States, 07601 |
Study Director: | Ronald Wiehle, PhD | Repros Therapeutics Inc. |
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 |
Drug-drug interactions DDI |
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 |