Effect of Food on the Pharmacokinetics of AQW051 in Japanese Healthy Male Subjects

Inclusion Criteria:

• Japanese healthy male subjects age 20 to 45 years of age, and in good health
• At screening and baseline, the subjects must be in good health as determined by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis.
• Body mass index within the range of 17 to 25 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

• Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening for all subjects. Smokers will be defined as any subject who reports tobacco use or has a urine cotinine ‘high’ level in checking by NicCheck® I.
• Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Acetaminophen is acceptable.
• Participation in any clinical investigation within 4 months prior to study start.
• Donation or loss of 400 mL or more of blood within 3 months; donation or loss of 200 mL or more of blood within 1 month; or donation of component blood within 2 weeks prior to study start.
• Subjects considered unsuitable for participation in the study within 2 weeks prior to dosing.
• A past medical history of clinically significant abnormality detected during electrocardiogram (ECG) examination or an evident family history (grandparents, parents and siblings) of a ECG abnormality (i.e. prolonged QT-interval syndrome).
• History of fainting, hypotension when standing up, arrhythmia.
• History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
• History of clinically significant drug allergy, history or presence of atopic allergy (asthma, urticaria, eczematous dermatitis) unless inactive seasonal allergy, or history of food allergy. A known hypersensitivity to the study drug or drugs similar to the study drug.
• 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 immunodeficiency diseases, including a positive HIV test result.
• A positive Hepatitis B surface antigen (HBsAg), Hepatitis C or Syphilis test result.
• History of drug or alcohol abuse within the 12 months prior to study participation or evidence of such abuse as indicated by the laboratory assays conducted at screening.

Other protocol-defined inclusion/exclusion criteria may apply