de Novo Liver Transplantation Clinical Trial
Official title:
An Open-label, Two-period, Multi-center, Single Dose Study to Assess the Pharmacokinetics of AEB071 in de Novo Liver Transplant Patients
| NCT number | NCT00545259 |
| Other study ID # | CAEB071B2101 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | |
| Last updated | |
| Start date | October 2007 |
| Verified date | February 2008 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The study will evaluate the pharmacokinetic profile of AEB071 in the immediate post-transplant period in patients who have undergone their first liver transplant.
| Status | Completed |
| Enrollment | 13 |
| Est. completion date | |
| Est. primary completion date | February 2009 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Novartis investigative site | Berlin | |
| Italy | Novartis Investigative Site | Padova | |
| Switzerland | Novartis investigative site | Zurich |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis |
Germany, Italy, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | -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 | -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, a-1 acid glycoprotein concentration & pharmacokinetics AEB071 |