de Novo Liver Transplantation
Conditions
Keywords
Organ transplant, liver, pharmacokinetics, AEB071, immunosuppression
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.
Interventions
DRUGAEB071
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -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
| Measure | Time frame |
|---|---|
| -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 | — |
Countries
Germany, Italy, Switzerland
Outcome results
None listed