drugset / Trial / NCT01975337

Pharmacokinetics and Safety of Alisporivir in Subjects With End Stage Renal Disease on Hemodialysis Compared to Healthy Subjects

NCT01975337

Phase 1 Completed 16 enrolled Debiopharm International SA
Non-randomizedParallel-groupOpen-label

Summary

The primary objective of the study was to compare the single dose pharmacokinetics of alisporivir in subjects with end stage renal disease (ESRD) on hemodialysis to those of matched healthy subjects. The secondary objective was to evaluate the safety and tolerability of a single dose of alisporivir when administered to subjects with ESRD.

Timeline

Start
2013-08
Primary completion
2014-02
Completion
2014-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Alisporivir Protein / enzyme biologic 400 mg Oral