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Evaluation of Renal Function Impairment on the Pharmacokinetics of LEE011

NCT ID: NCT02431481

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-23

Study Completion Date

2018-05-11

Brief Summary

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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

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Conditions

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Normal Renal Function Impaired Renal Function

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normal renal function

Normal renal function; matched demography to renal impariment cohorts

Group Type EXPERIMENTAL

LEE011

Intervention Type DRUG

400 mg

Severe renal impairment

Severe decrease in GFR (15-29 ml/min)

Group Type EXPERIMENTAL

LEE011

Intervention Type DRUG

400 mg

End Stage Renal Disease

End stage renal disease not on dialysis; GFR \<15 ml/min

Group Type EXPERIMENTAL

LEE011

Intervention Type DRUG

400 mg

Mild renal impairment

Mild decrease in GFR (60-89 ml/min)

Group Type EXPERIMENTAL

LEE011

Intervention Type DRUG

400 mg

Moderate renal impairment

Moderate decrease in GFR (30-59 ml/min)

Group Type EXPERIMENTAL

LEE011

Intervention Type DRUG

400 mg

Interventions

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LEE011

400 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female (sterile or postmenopausal) subjects between 18-75 (both inclusive) years of age and healthy as determined by absence of clinically significant deviation from normal in medical history, physical examination, vital signs, electrocardiograms, and clinical laboratory determinations (except for renal impaired subjects).
* Subjects must have a BMI between 18 kg/m2 and 38 kg/m2 and weight at least 50 kg and no more than 120 kg.

* An absolute GFR as determined by MDRD equation and conversion within normal range as determined by GFR \> 90 mL/min


\- Subjects must have documented stable renal disease without evidence of renal progressive disease (stable renal disease is defined as no significant change, such as a stable absolute GFR, for 4 weeks prior to study entry.

Exclusion Criteria

* Subject has received a renal transplant at any time in the past and is on immunosuppressant therapy
* History or presence of impaired cardiac function
* Any surgical or medical condition that may significantly alter the absorption, distribution, metabolism, or excretion of drugs
* Administration of CYP3A4/5 inhibitors or inducers or CYP3A4 substrates with narrow therapeutic windows
* Administration of medications that prolong the QT interval
* Subject has a history of immunodeficiency diseases, including HIV, as confirmed by (HIV-1, HIV-2) test
* Receipt of investigational product in another clinical trial within 4 weeks of dosing


* Severe albuminuria \> 300 mg/day
* Subjects undergoing any method of dialysis
* Subjects with renal impairment due to hepatic disease (hepatorenal syndrome)

Other protocol-defined Inclusion/Exclusion may apply.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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DaVita Clinical Research

Minneapolis, Minnesota, United States

Site Status

Novartis Investigative Site

Sofia, , Bulgaria

Site Status

Novartis Investigative Site

Prague, Czech Republic, Czechia

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Countries

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Romania United States Bulgaria Czechia Germany

References

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Ji Y, Yartsev V, Quinlan M, Serra P, Wang Y, Chakraborty A, Miller M. Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials. Clin Pharmacokinet. 2023 Mar;62(3):493-504. doi: 10.1007/s40262-022-01206-2. Epub 2023 Feb 17.

Reference Type DERIVED
PMID: 36800111 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17418

Results for CLEE011A2116 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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CLEE011A2116

Identifier Type: -

Identifier Source: org_study_id