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Evaluation of Renal Function Impairment on the Pharmacokinetics of LEE011

NCT02431481 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2020-12-19

No results posted yet for this study

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

DRUG

LEE011

400 mg

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-23
Primary Completion
2017-09-14
Completion
2018-05-11
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02431481 on ClinicalTrials.gov