Pharmacokinetic Study of AEB071 in Patients Following Liver Transplantation

Novartis13 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

de Novo Liver Transplantation

Interventions

AEB071DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Novartis investigative site

Berlin, Germany

Novartis Investigative Site

Padua, Italy

Novartis investigative site

Zurich, Switzerland

Outcomes

Primary Outcomes

-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

Secondary Outcomes

-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

Data from ClinicalTrials.gov

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