NCT01975337

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

An Open-label Study to Evaluate the Pharmacokinetics and Safety of a Single Oral Dose of Alisporivir (DEB025) in Subjects With End Stage Renal Disease on Hemodialysis Compared to Matched Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Failure, Chronic

Interventions

Type	Name	Description
DRUG	Alisporivir	Alisporivir supplied as 200 mg oral capsules in blister packs (7 units per blister pack)

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-11-04
• Last updated: 2016-08-17

Locations

1 site across 1 country: United States