Overview

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

Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Debiopharm International SA
Criteria
Inclusion Criteria:

- Provides written informed consent before any assessment is performed

- Matched healthy participants are in good health as determined by past medical history,
physical examination, vital signs, laboratory tests, and other assessments

- ESRD participants are on a protocol-defined stable hemodialysis regimen and have no
evidence of hepatic decompensation, with vital signs and other tests within
protocol-specified limits

- Weighs at least 50 kg

- Is able to communicate well with the investigator, to understand and comply with the
requirements of the study.

Exclusion Criteria:

- Has history or current use of over-the-counter medications, dietary supplements, or
drugs (including nicotine and alcohol) outside protocol-specified parameters

- Has signs, symptoms or history of any condition that, per protocol or in the opinion
of the investigator, might compromise:

1. the safety or well-being of the participant or study staff;

2. the safety or well-being of the participant's offspring (such as through
pregnancy or breast-feeding);

3. the analysis of results