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

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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: AEB071


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AEB071|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of ascending single oral doses of AEB071 in healthy subjects. |  |  | 
| Maximum Tolerated Dose |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, tolerability, pharmacokinetics, pharmacodynamics, AEB071, healthy subjects, transplantation