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
  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:


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
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, see Learn About Clinical Studies.

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 August 28, 2014