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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00409929

Enrollment

Registered

2006-12-12

Start date

2006-06-30

Completion date

Unknown

Last updated

2010-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

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

Brief summary

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

Interventions

DRUGAEB071

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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/

Design outcomes

Primary

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

Secondary

Measure	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	—

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026