Evaluation of Renal Function Impairment on the Pharmacokinetics of LEE011

Phase 1

Completed

• Conditions: Normal Renal Function; Impaired Renal Function
• Interventions: Drug: LEE011

• Registration Number: NCT02431481
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-02
• Study First Submitted QC: 2015-04-27
• Study First Posted: 2015-05-01
• Study Start: 2015-10-23
• Primary Completion: 2017-09-14
• Study Completion: 2018-05-11
• Status Verified: 2019-02
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild renal impairment	LEE011	Mild decrease in GFR (60-89 ml/min)
Moderate renal impairment	LEE011	Moderate decrease in GFR (30-59 ml/min)
Normal renal function	LEE011	Normal renal function; matched demography to renal impariment cohorts
Severe renal impairment	LEE011	Severe decrease in GFR (15-29 ml/min)
End Stage Renal Disease	LEE011	End stage renal disease not on dialysis; GFR \<15 ml/min

Primary Outcome Measures

Name	Time	Method
Primary Pharmacokinetics (PK) parameters of LEE011 when appropriate	14 days	Primary composite PK parameters: Cmax, AUClast, AUCinf, and CL/F. To determine the impact of various degrees of renal impairment on primary PK parameters of LEE011 following a single 400mg oral dose

Secondary Outcome Measures

Name	Time	Method
Frequency of adverse events (AEs)	From consent to 28 days post-dose	Safety profile of a single dose of LEE011 in healthy subjects and subjects with varying degrees of hepatic function includes changes observed in physical examination, changes in vital signs, changes in electrocardiograms (ECGs), abnormal laboratory results.
PK parameters of LEQ803 (i.e., Cmax, AUClast, AUCinf, Tmax, T1/2)	14 days	Composite PK parameters of LEQ803: Cmax, AUClast, AUCinf, Tmax, T1/2. To evaluate the PK profile of LEQ803 in subjects with various degrees of renal impairment following a single 400 mg oral dose
Secondary PK parameters of LEE011 when appropriate	14 days	Secondary composite PK parameters of LEE011: Tmax, T1/2, Vz/F, and CLr. To determine the impact of various degrees of renal impairment on secondary PK parameters of LEE011 following a single 400 mg oral dose

Trial Locations

Locations (2)

DaVita Clinical Research; 🇺🇸 Minneapolis, Minnesota, United States

Novartis Investigative Site; 🇩🇪 Berlin, Germany