Safety of AEB071 in Healthy Volunteers and to Compare the Ethnicity, Metabolic, and Safety Effects Between Caucasian and Japanese Healthy Subjects

NCT ID: NCT00416546

Last Updated: 2008-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2007-10-31

Brief Summary

This is a study to assess the safety effects after multiple doses of AEB071 in healthy volunteers and to compare the ethnicity, metabolic, and safety effects between Caucasian and Japanese healthy subjects receiving single and multiple doses of AEB071.

Conditions

Healthy

Keywords

Healthy Caucasians; Healthy Japanese subjects; Immunosuppressant; early T-cell activation blockers; inhibition of protein kinase C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

AEB071

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy, male or female subjects having provided written, informed, consent before entering the study. Light smokers (≤10 cigarettes/day) will be eligible for inclusion in this study. Smokers will be defined as any subject who reports cigarette use or has a urine cotinine greater than 500 ng/mL.
• Female subjects must be either surgically sterilized at least 6 months or practicing an acceptable form of birth control (i.e. double barrier method - intrauterine device plus condom, spermicidal gel plus condom).
• Subjects must have a body weight between 45 and 90 kg and a body mass index (BMI) between 18-28 kg/m2.
• Japanese subjects of 1st, 2nd, or 3rd generation ethnic origin or Caucasian.
• Japanese subjects will be defined as being of Japanese ethnicity with all 4 grandparents of Japanese descent. Generations will be defined as follows:

• 'First generation' Japanese are subjects who were born in Japan to parents of Japanese ethnicity.
• 'Second generation' will be defined as subjects who were born outside of Japan to 1st generation Japanese parents.
• 'Third generation' will be defined as subjects born outside of Japan to 2nd generation Japanese parents, i.e. 4 grandparents from Japan but both parents and subject born elsewhere.
• Caucasians are defined as subjects with all four grandparents of European descent.

Exclusion Criteria

• Presence and/or history of a clinically significant illness within two weeks prior to dosing, history of drug or alcohol abuse within the 12 months prior to dosing, use of any prescription drug or over-the-counter (OTC) medication (acetaminophen is acceptable) within 14 days prior to dosing.
• Presence of a clinically significant systemic illness, active infectious process (viral or bacterial), e.g., cold sore, or documented drug allergies that may deteriorate or affect the subject's safety or ability to cooperate during the study.
• Laboratory or clinical evidence suggestive of liver or renal disease, history of heart disease, history of autonomic dysfunction (e.g. history of fainting, orthostatic hypotension, sinus arrhythmia), history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated), history of major gastrointestinal disease, history or clinical evidence of pancreatic injury or pancreatitis
• Subjects with a resting heart rate < 50 beats per minute (bpm)
• Subjects with systolic blood pressure < 90 or diastolic blood pressure < 50.
• Subjects with lymphocyte counts less than 1200/mm3 or total white blood cell (WBC) greater than 10000/mm3 at baseline
• A past medical history of clinically significant electrocardiogram (ECG) abnormalities or a family history of a prolonged QT-interval syndrome.
• Subjects who intend to or have received any live attenuated vaccines 4 weeks prior to or during the study period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis

Principal Investigators

Novartis

Role: PRINCIPAL_INVESTIGATOR

Novartis

Locations

Novartis Investigative Site

Dorval, Quebec, Canada

Countries

Canada

Other Identifiers

CAEB071A2113

Identifier Type: -

Identifier Source: org_study_id