Pharmacokinetic Study of AEB071 in Patients Following Liver Transplantation

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00545259

First received: October 15, 2007

Last updated: April 8, 2011

Last verified: February 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

October 15, 2007

Last Updated Date

April 8, 2011

Start Date ^ICMJE

October 2007

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

-Pharmacokinetic of AEB071 & its primary metabolite, AEE800 at predose & up to 72 hours post-operatively -Safety & tolerability (vital signs,ECGs,clinical lab evaluations,seroius/adverse events) -AEB071,AEE800 & tacrolimus in blood for both Periods [ Time Frame: at predose & 16 timepoints post-dose ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00545259 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

-Pharmacokinetics of tacrolimus in presence of AEB071 -Biliary excretion of AEB071 & primary metabolite (AEE800) from patients with a T-tube -Relationship of free drug concentration, α-1 acid glycoprotein concentration & pharmacokinetics AEB071

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pharmacokinetic Study of AEB071 in Patients Following Liver Transplantation

Official Title ^ICMJE

An Open-label, Two-period, Multi-center, Single Dose Study to Assess the Pharmacokinetics of AEB071 in de Novo Liver Transplant Patients

Brief Summary

The study will evaluate the pharmacokinetic profile of AEB071 in the immediate post-transplant period in patients who have undergone their first liver transplant.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

de Novo Liver Transplantation

Intervention ^ICMJE

Drug: AEB071

Study Arm (s)

Experimental: 1

AEB071

Intervention: Drug: AEB071

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Primary liver transplant recipients.
Transplanted liver functioning at an acceptable level by 24 h post-transplant
Patients started on tacrolimus therapy within 12 h post-transplant

Exclusion Criteria:

Previous transplantation or multiple organs transplantation
Acute rejection
Non-heart beating donor

Other protocol-defined inclusion/exclusion criteria may apply.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, Italy, Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00545259

Other Study ID Numbers ^ICMJE

CAEB071B2101

Has Data Monitoring Committee

Responsible Party

External Affairs, Novartis

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Novartis

Investigator site

Information Provided By

Novartis

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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