NCT02431481

Evaluation of Renal Function Impairment on the Pharmacokinetics of LEE011

A Phase I, Open Label, Multicenter, Parallel-group, Single Dose Two-staged Study to Evaluate the Pharmacokinetics and Safety of a Single 400 mg Oral Dose of LEE011 in Subjects With Varying Degrees of Impaired Renal Function Compared to Matched Healthy Volunteers With Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Normal Renal Function
• Impaired Renal Function

Interventions

Type	Name	Description
DRUG	LEE011	400 mg

Timeline

• Start date: 2015-10-23
• Primary completion: 2017-09-14
• Completion: 2018-05-11
• First posted: 2015-05-01
• Last updated: 2020-12-19

Locations

4 sites across 4 countries: United States, Bulgaria, Czechia, Germany

Regulatory

• FDA-regulated drug study