At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 enrolled
Drug / intervention
BAF312drug
Likely dose
BAF312 0.25 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 Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of BAF312 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Control Subjects.
In Brief
A Phase 1 clinical trial evaluating BAF312 for Hepatic Impairment. Completed, enrolled 40 participants across 3 sites in 2 countries.
Detailed Summary
This study will investigate the pharmacokinetics of BAF312 in patients with mild, moderate and severe hepatic impairment compared to healthy control subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Impairment
CountriesHungary, Russia
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 2012
Enrollment StartOct 2012
Primary CompletionMar 2014
TodayJul 2026
First PostedMar 29, 2012
Enrollment StartOct 1, 2012
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.3 years ago
Interventions
BAF312drug
Treatment with a single oral dose of 0.25 mg BAF312