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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00409929
• Collaborator: (none)
• Enrollment: 16
• Location: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: AEB071	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Jul 1, 2006

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability of ascending single oral doses of AEB071 in healthy subjects. []

2. Maximum Tolerated Dose []

Secondary Outcome Measures

1. Assess the pharmacokinetics of single oral doses of AEB071 at the end of study []

2. Measure inhibition of lymphocytes activation following rising oral doses of AEB071 in healthy subjects after each single dose []

3. Measure the pharmacokinetic/pharmacodynamic relationship of single rising oral doses of AEB071 in healthy subjects after each single dose []

4. Conduct exploratory genomic studies to identify gene expression patterns of blood cells at the end of study []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Bern		Switzerland

Sponsors and Collaborators

• Novartis

Investigators

• Principal Investigator: Novartis, Investigator site

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00409929
• Other Study ID Numbers: CAEB071A2114
• First Posted: Dec 12, 2006
• Last Update Posted: Oct 19, 2010
• Last Verified: Oct 1, 2010

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

Study Results

No Results Posted as of Oct 19, 2010