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

NCT00409929 | Completed Phase 1

• 1 other identifier: CAEB071A2114
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of ascending single oral doses of AEB071 in healthy subjects.

• Maximum Tolerated Dose

Secondary Outcomes (4)

• 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

Interventions

AEB071 DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Investigative Site

Bern, Switzerland

Location

MeSH Terms

Interventions

sotrastaurin

Study Officials

• Novartis

  Investigator site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 11, 2006
• First Posted: December 12, 2006
• Study Start: June 1, 2006
• Primary Completion: July 1, 2006
• Last Updated: October 19, 2010

Record last verified: 2010-10

Locations

CH (1)