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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
  Purpose

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


Condition Intervention Phase
de Novo Liver Transplantation
 Drug: AEB071
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open-label, Two-period, Multi-center, Single Dose Study to Assess the Pharmacokinetics of AEB071 in de Novo Liver Transplant Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • -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 Outcome Measures:
  • -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

Enrollment: 13
Study Start Date: October 2007
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AEB071
 Drug: AEB071

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545259

Locations
Germany
Novartis investigative site
Berlin, Germany
Italy
Novartis Investigative Site
Padova, Italy
Switzerland
Novartis investigative site
Zurich, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigator site
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00545259     History of Changes
Other Study ID Numbers: CAEB071B2101
Study First Received: October 15, 2007
Last Updated: April 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Organ transplant, liver, pharmacokinetics, AEB071, immunosuppression

ClinicalTrials.gov processed this record on May 16, 2013