Pharmacokinetics and Safety of Alisporivir in Subjects With End Stage Renal Disease on Hemodialysis Compared to Healthy Subjects
Completed · Phase 1
Conditions studied: Kidney Failure, Chronic
In brief
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.
Key facts
- Study ID
- NCT01975337
- Run by
- Debiopharm International SA
- People needed
- 16
- Starts
- 2013-08-01
- Expected to finish
- 2014-02-01
- Last updated by the study team
- 2016-08-17
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Novartis Investigative Site — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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