Evaluation of Hepatic Function Impairment on the Pharmacokinetics of LEE011
A Phase I, Open Label, Multi-center, Parallel Cohort, Single Dose Study to Evaluate the Pharmacokinetics of LEE011 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function.
Sponsor: Novartis Pharmaceuticals
Listed as NCT02388620, this PHASE1 trial focuses on Impaired Hepatic Function and Normal Hepatic Function and remains completed. Sponsored by Novartis Pharmaceuticals, it has been updated 9 times since 2015, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
9 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE1
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE1
-
Jan 2019 — Jan 2021 [monthly]
Completed PHASE1
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Jun 2018 — Jan 2019 [monthly]
Completed PHASE1
▶ Show 4 earlier versions
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Jan 2018 — Jun 2018 [monthly]
Completed PHASE1
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Jul 2017 — Jan 2018 [monthly]
Completed PHASE1
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Feb 2017 — Jul 2017 [monthly]
Completed PHASE1
Status: Recruiting → Completed
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Jan 2017 — Feb 2017 [monthly]
Recruiting PHASE1
First recorded
Mar 2015
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Novartis Pharmaceuticals
For direct contact, visit the study record on ClinicalTrials.gov .