A two part, randomized, placebo controlled study to evaluate the pharmacokinetics and cardiovascular pharmacodynamics of AEB071 in combination with ritonavir in healthy volunteers

• Conditions: Healthy volunteers

• Registration Number: EUCTR2007-004844-59-FR
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-18
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Healthy, male or female subjects, 18 to 45 years of age having provided written informed consent before entering the study. Only non-smokers will be eligible. Smokers will be defined as any subject who reports cigarette use or has a urine cotinine greater than 500 ng/mL.
•Subjects must have a body weight between 50 and 90 kg and a BMI between 18-28 kg/m2.
•Female subjects must be post menopausal or surgically sterilized

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Presence and/or history of a clinically significant illness in the two weeks prior to dosing, history of drug or alcohol abuse, use of any prescription drug or over-the-counter (OTC) medication (acetaminophen is acceptable) or herbal products in the 14 days prior to dosing.
•A marked baseline prolongation of QT/QTcF interval (e.g., repeated demonstration of a QTcF interval >500);
•A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome);
•Presence of clinically significant illness, active infectious process (viral or bacterial) including (but not limited to) history of herpetic infections, positive tuberculosis tests, other infections at risk of relapse or documented drug allergies that may affect the subject’s safety 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 major gastrointestinal disease, history or clinical evidence of pancreatic injury or pancreatitis.
•Subjects with a resting heart rate < 40 bpm or > 90 bpm
•Subjects with systolic blood pressure < 90 or diastolic blood pressure < 50 mmHg.
•Subjects with lymphocyte counts less than 1000/mm3 or total WBC greater than 11000/mm3 at baseline
•Subject who intend to or have received any live attenuated vaccines 4 weeks prior to or during the study period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified