A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of AEB071

A Randomized, Double-blind, Placebo-controlled, Time Lagged, Parallel Group, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral AEB071 Doses Greater Than 500 mg in Healthy Subjects

This study will evaluate the safety and tolerability of ascending single oral doses greater than 500 mg of AEB071 in healthy subjects

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: AEB071

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and/or female subjects from 18-55 years of age and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests at screening.
• Female subjects had to either have been surgically sterilized or be postmenopausal.

Exclusion Criteria:

• Smokers
• Use of any prescription drug or over-the-counter medication within 2 weeks prior to dosing, or 2 months for inducers or inhibitors of cytochrome CYP4503A4 (paracetamol acceptable)
• Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing
• A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome
• History of History of fainting, hypotension when standing up, arrhythmia, acute or chronic bronchospastic disease
• History of clinically significant drug allergy; atopic allergy or a known hypersensitivity to any of the study drugs or drugs similar to the study drugs
• Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study
• History of immunocompromise (including a positive HIV test result) or drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse or a current positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

Additional protocol-defined inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Maximum Tolerated Dose
Safety and tolerability of ascending single oral doses of AEB071 in healthy subjects.

Secondary Outcome Measures

Outcome Measure
Assess the pharmacokinetics of single oral doses of AEB071 at the end of study
Measure inhibition of lymphocytes activation following rising oral doses of AEB071 in healthy subjects after each single dose
Measure the pharmacokinetic/pharmacodynamic relationship of single rising oral doses of AEB071 in healthy subjects after each single dose
Conduct exploratory genomic studies to identify gene expression patterns of blood cells at the end of study

Collaborators and Investigators

• Sponsor: Novartis

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: December 11, 2006
• First Submitted That Met QC Criteria: December 11, 2006
• First Posted (Estimate): December 12, 2006

Study Record Updates

• Last Update Posted (Estimate): October 19, 2010
• Last Update Submitted That Met QC Criteria: October 18, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Safety, tolerability, pharmacokinetics, pharmacodynamics, AEB071, healthy subjects, transplantation
• Other Study ID Numbers: CAEB071A2114