- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00409500
Effect of Food on the Pharmacokinetics of AQW051 in Japanese Healthy Male Subjects
June 21, 2007 updated by: Novartis
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
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.
Study Overview
Study Type
Interventional
Enrollment
54
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo, Japan
- Novartis Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Safety and tolerability of single oral doses of AQW051 in Japanese healthy male subjects at the end of the study
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Secondary Outcome Measures
Outcome Measure |
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Pharmacokinetics of single oral doses of AQW051 in Japanese healthy male subjects at the end of the study
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Effect of food on the pharmacokinetics of AQW051 after each dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Novartis Japan, Investigator site
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Study Registration Dates
First Submitted
December 8, 2006
First Submitted That Met QC Criteria
December 8, 2006
First Posted (Estimate)
December 11, 2006
Study Record Updates
Last Update Posted (Estimate)
June 22, 2007
Last Update Submitted That Met QC Criteria
June 21, 2007
Last Verified
June 1, 2007
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CAQW051A1101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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