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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00409929
First received: December 11, 2006
Last updated: October 18, 2010
Last verified: October 2010
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Enrollment: 16
Study Start Date: June 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00409929     History of Changes
Other Study ID Numbers: CAEB071A2114
Study First Received: December 11, 2006
Last Updated: October 18, 2010
Health Authority: Switzerland: Swissmedic

Keywords provided by Novartis:
Safety, tolerability, pharmacokinetics, pharmacodynamics, AEB071, healthy subjects, transplantation

ClinicalTrials.gov processed this record on August 28, 2014