Pharmacokinetic Study of AEB071 in Patients Following Liver Transplantation
- Registration Number
- NCT00545259
- Lead Sponsor
- Novartis
- Brief Summary
The study will evaluate the pharmacokinetic profile of AEB071 in the immediate post-transplant period in patients who have undergone their first liver transplant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 AEB071 AEB071
- Primary Outcome Measures
Name Time Method -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 at predose & 16 timepoints post-dose
- Secondary Outcome Measures
Name Time Method -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
Trial Locations
- Locations (2)
Novartis investigative site
🇨🇭Zurich, Switzerland
Novartis Investigative Site
🇮🇹Padova, Italy