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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00409500
First received: December 8, 2006
Last updated: June 21, 2007
Last verified: June 2007
  Purpose

This study will evaluate safety, tolerability and pharmacokinetics of individual oral doses of AQW051 in Japanese healthy male subjects, and will also evaluate the effect of food on the pharmacokinetics of AQW051.


Condition Intervention Phase
Healthy
Drug: AQW051
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Interleaved, Ascending Dose Study, to Evaluate Safety, Tolerability and Pharmacokinetics of Single Oral Doses of AQW051; to Evaluate the Effect of Food on the Pharmacokinetics of AQW051, in Japanese Healthy Male Subjects

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety and tolerability of single oral doses of AQW051 in Japanese healthy male subjects at the end of the study

Secondary Outcome Measures:
  • Pharmacokinetics of single oral doses of AQW051 in Japanese healthy male subjects at the end of the study
  • Effect of food on the pharmacokinetics of AQW051 after each dose

Estimated Enrollment: 54
Study Start Date: October 2006
  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409500

Locations
Japan
Novartis Investigative Site
Tokyo, Japan
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Japan Investigator site
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00409500     History of Changes
Other Study ID Numbers: CAQW051A1101
Study First Received: December 8, 2006
Last Updated: June 21, 2007
Health Authority: Japan: MHLW (Ministry of Health, Labour and Welfare)

Keywords provided by Novartis:
Safety, tolerability, pharmacokinetics, AQW051, food, Japanese, healthy male subjects
Healthy volunteers study

ClinicalTrials.gov processed this record on November 24, 2014