At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 18 enrolled
Drug / intervention
Proellex +5 moredrug
Likely dose
Proellex 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Proellex, CYP1A2 probe, and 4 other interventions for Drug Interactions. Completed, enrolled 18 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDrug Interactions
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2008
First PostedAug 2008
Primary CompletionSep 2008
Study CompletionOct 2008
TodayJul 2026
First PostedAug 26, 2008
Enrollment StartJul 1, 2008
Primary CompletionSep 1, 2008
Study CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.8 years ago
Interventions
Proellexdrug
2, 25 mg Proellex capsules administered daily
CYP1A2 probedrug
Caffeine (200 mg)
CYP2C9 probedrug
Tolbutamide (250 mg)
CYP2C19 probedrug
Omeprazole (20 mg)
CYP2D6 probedrug
Dextromethorphan (30 mg)
CYP3A4 probedrug
Midazolam (2mg)