A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of AEB071 - Full Text View

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: AEB071	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

Official Title:	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

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	24
Study Start Date:	June 2006

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409929

Locations


Switzerland
	Novartis Investigative Site
	Bern, Switzerland

Sponsors and Collaborators

Novartis

Investigators


Principal Investigator:	Novartis	Investigator site

More Information

Study ID Numbers:	CAEB071A2114
First Received:	December 11, 2006
Last Updated:	June 21, 2007
ClinicalTrials.gov Identifier:	NCT00409929
Health Authority:	Switzerland: Swissmedic

Keywords provided by Novartis:

Safety, tolerability, pharmacokinetics, pharmacodynamics, AEB071, healthy subjects, transplantation

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on October 22, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00409929