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Completed

NCT Number: NCT00409929

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

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site

Bern, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AEB071

Drug

Primary outcomes

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

  2. Maximum Tolerated Dose

Secondary outcomes

  1. Assess the pharmacokinetics of single oral doses of AEB071 at the end of study

  2. Measure inhibition of lymphocytes activation following rising oral doses of AEB071 in healthy subjects after each single dose

  3. Measure the pharmacokinetic/pharmacodynamic relationship of single rising oral doses of AEB071 in healthy subjects after each single dose

  4. Conduct exploratory genomic studies to identify gene expression patterns of blood cells at the end of study

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
First posted
Dec 12, 2006
Registry last updated
Oct 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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