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

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:

• the safety or well-being of the participant or study staff;
• the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
• the analysis of results