Phase 1
Completed N=18
Open-Label, Multiple-Dose, Non-Randomized Study to Assess Drug-Drug Interactions of Proellex® in Female Subjects
Drug Interactions
Source: ClinicalTrials.gov NCT00741468 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Plasma AUC Ratio of Day 1 and Day 8 — 1.093; 1.029; 1.104; 1.914 Ratio of geometric means Day 8 to Day 1
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma AUC Ratio of Day 1 and Day 8 |
1.093; 1.029; 1.104; 1.914; 2.245 | — |
Eligibility 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"
Data sourced from ClinicalTrials.gov (NCT00741468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.