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OpenTrials
Completed

NCT Number: NCT00545259

Pharmacokinetic Study of AEB071 in Patients Following Liver Transplantation

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

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Key information

Conditions

de Novo Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis investigative site, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AEB071

Drug

Primary outcomes

  1. -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

  1. -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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
First posted
Oct 17, 2007
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.