Pharmacokinetic Study of AEB071 in Patients Following Liver Transplantation

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00545259
• Collaborator: (none)
• Enrollment: 13
• Locations: 3
• Arm: 1
• Patients Per Site: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
de Novo Liver Transplantation	Drug: AEB071	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: An Open-label, Two-period, Multi-center, Single Dose Study to Assess the Pharmacokinetics of AEB071 in de Novo Liver Transplant Patients
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 AEB071	Drug: AEB071

Outcome Measures

Primary Outcome Measures

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 [at predose & 16 timepoints post-dose]

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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/exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis investigative site	Berlin		Germany
2	Novartis Investigative Site	Padova		Italy
3	Novartis investigative site	Zurich		Switzerland

Sponsors and Collaborators

• Novartis

Investigators

• Principal Investigator: Novartis, Investigator site

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Results from CAEB071B2101 can be found on the Novartis Clinical Trial Results website

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00545259
• Other Study ID Numbers: CAEB071B2101
• First Posted: Oct 17, 2007
• Last Update Posted: Dec 8, 2020
• Last Verified: Feb 1, 2008

• Keywords provided by , ,: Organ transplant, liver, pharmacokinetics, AEB071, immunosuppression

Study Results

No Results Posted as of Dec 8, 2020