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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AEB071 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AEB071 | Drug |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Investigator site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis investigative site | Berlin | Germany | ||||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results from CAEB071B2101 can be found on the Novartis Clinical Trial Results website | View source |
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| ID | Term |
|---|---|
| C543528 | sotrastaurin |
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| Padova |
| Italy |
| Novartis investigative site | Zurich | Switzerland |