Evaluation of Renal Function Impairment on the Pharmacokinetics of LEE011
Completed · Phase 1
Conditions studied: Normal Renal Function, Impaired Renal Function
In brief
The purpose of this study is to characterize the PK and safety profile of LEE011 following a single oral dose in adult subjects with various degrees of renal impairment compared to a matched group of healthy subjects with normal renal function.
Key facts
- Study ID
- NCT02431481
- Run by
- Novartis Pharmaceuticals
- People needed
- 38
- Starts
- 2015-10-23
- Expected to finish
- 2018-05-11
- Last updated by the study team
- 2020-12-19
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
Where it is running
- DaVita Clinical Research — Minneapolis, Minnesota, United States
- Novartis Investigative Site — Sofia, Bulgaria
- Novartis Investigative Site — Prague, Czech Republic, Czechia
- Novartis Investigative Site — Berlin, Germany
Full record on ClinicalTrials.gov
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