Status:
COMPLETED
Safety and Pharmacokinetics of LHT344 in Chinese Healthy Subjects
Lead Sponsor:
Novartis
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate safety and pharmacokinetics of a single and multiple dose of LHT344 in 12 Chinese healthy subjects. This study is not recruiting subjects in the United States...
Eligibility Criteria
Inclusion
- Healthy, non-smoking, male or female subjects age 18 to 45 years of age
- In good health as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation
- Body mass index within the range of 19 to 24 kg/m2 and weigh at least 50 kg
Exclusion
- Smokers
- 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. Paracetamol is acceptable.
- Participation in any clinical investigation within 3 months prior to dosing.
- Donation or loss of 400 mL or more of blood within 12 weeks prior to first dosing required by local regulation.
- Significant illness within 2 weeks prior to dosing.
- A past personal or close family medical history of clinically significant cardiac abnormalities such as a myocardial infarction, angina, arterial fibrillation, arrhythmia or hypertension.
- History of
- fainting, low blood pressure upon standing, irregular heart beats
- acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
- clinically significant drug allergy, history or presence of atopic allergy (asthma, urticaria, eczematous dermatitis)
- known hypersensitivity to the study drug or similar drugs
- surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or may jeopardize the subject participation in the study
- immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- drug or alcohol abuse within the 12 months prior to study participation
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00414778
Start Date
October 1 2006
Last Update
January 13 2011
Active Locations (1)
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1
Novartis Investigative Site
Beijing, China