NCT02388620

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability of a single oral dose of LEE011 in subjects with varying degrees of impaired hepatic function (based on Child-Pugh classification) as compared to demographically-matched control subjects with normal hepatic function.

Conditions

• Normal Hepatic Function
• Impaired Hepatic Function

Interventions

Type	Name	Description
DRUG	LEE011	400 mg

Timeline

• Start date: 2015-03-25
• Primary completion: 2017-01-09
• Completion: 2017-01-09
• First posted: 2015-03-17
• Last updated: 2020-12-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study