At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
Proellexdrug
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, Two-stage, Dose-escalation, Parallel Group Study to Evaluate the Safety and Pharmacokinetics Profile of Proellex® (CDB-4124) in Female Patients With Impaired Hepatic Function and Healthy Adult Volunteers
In Brief
A Phase 1 clinical trial evaluating Proellex for Impaired Liver Function. Completed, enrolled 16 participants across 2 sites.
Detailed Summary
This study will evaluate the safety and pharmacokinetics of two doses of orally administered Proellex® in female patients with impaired hepatic function and healthy volunteers with normal hepatic function.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImpaired Liver Function
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2008
Enrollment StartOct 2008
Primary CompletionMay 2009
Study CompletionJun 2009
TodayJul 2026
First PostedAug 26, 2008
Enrollment StartOct 1, 2008
Primary CompletionMay 1, 2009
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.8 years ago
Interventions
Proellexdrug
Proellex 25 mg capsule, single dose