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Pharmacokinetic Study of AEB071 in Patients Following Liver Transplantation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00545259
First Posted: October 17, 2007
Last Update Posted: April 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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
Intervention Model: Single Group Assignment
Masking: None (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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00545259     History of Changes
Other Study ID Numbers: CAEB071B2101
First Submitted: October 15, 2007
First Posted: October 17, 2007
Last Update Posted: April 11, 2011
Last Verified: February 2008

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