At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 17 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.
A Phase I, Open-Label, Randomized, Single-Center, Unblinded, Single-Dose, Five-Way Crossover Study of the Safety and PK Properties of Proellex®
In Brief
A Phase 1 clinical trial evaluating Proellex for Pharmacokinetics. Completed, enrolled 17 participants across 1 site.
Detailed Summary
Study to evaluate the PK of 25 mg and 50 mg of Proellex from 2 different suppliers in the fed and fasting states.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacokinetics
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2008
First PostedSep 2008
Primary CompletionOct 2008
TodayJul 2026
First PostedSep 9, 2008
Enrollment StartAug 11, 2008
Primary CompletionOct 23, 2008
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.8 years ago
Interventions
Proellexdrug
25 mg capsule administered once orally after subjects have been fed; 25 mg capsule administered once orally while subjects are fasting; 2, 25 mg capsules administered once orally after subjects have been fed; 2, 25 mg capsules administered once orally while subjects are fasting; and 2, 25 mg capsules administered once orally while subjects are fasting