NCT01565902

Pharmacokinetics of BAF312 in Patients With Hepatic Impairment

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study will investigate the pharmacokinetics of BAF312 in patients with mild, moderate and severe hepatic impairment compared to healthy control subjects.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	BAF312	Treatment with a single oral dose of 0.25 mg BAF312

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2012-03-29
• Last updated: 2020-12-29
• Results posted: 2014-12-22

Locations

3 sites across 2 countries: Hungary, Russia