NCT00545259

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Last Updated

December 8, 2020

Status Verified

February 1, 2008

Enrollment Period

1.3 years

First QC Date

October 15, 2007

Last Update Submit

December 6, 2020

Conditions

de Novo Liver Transplantation

Keywords

Organ transplant, liver, pharmacokinetics, AEB071, immunosuppression

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (1)

1

EXPERIMENTAL

AEB071

Drug: AEB071

Interventions

AEB071DRUG
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previous transplantation or multiple organs transplantation
  • Acute rejection
  • Non-heart beating donor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Novartis investigative site

Berlin, Germany

Location

Novartis Investigative Site

Padua, Italy

Location

Novartis investigative site

Zurich, Switzerland

Location

Related Links

MeSH Terms

Interventions

sotrastaurin

Study Officials

  • Novartis

    Investigator site

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 15, 2007

First Posted

October 17, 2007

Study Start

October 1, 2007

Primary Completion

February 1, 2009

Last Updated

December 8, 2020

Record last verified: 2008-02

Locations

DE(1)IT(1)CH(1)