Clinical trial NCT00409929: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of AEB071
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety, tolerability, pharmacokinetics, pharmacodynamics, AEB071, healthy subjects, transplantation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Safety and tolerability of ascending single oral doses of AEB071 in healthy subjects.
measure: Maximum Tolerated Dose
Secondary outcomes:
measure: Assess the pharmacokinetics of single oral doses of AEB071 at the end of study
measure: Measure inhibition of lymphocytes activation following rising oral doses of AEB071 in healthy subjects after each single dose
measure: Measure the pharmacokinetic/pharmacodynamic relationship of single rising oral doses of AEB071 in healthy subjects after each single dose
measure: Conduct exploratory genomic studies to identify gene expression patterns of blood cells at the end of study
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: Investigator site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References: