Safety and Pharmacokinetics of LHT344 in Chinese Healthy Subjects
Overview
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.
Full Title of Study: “A Single-center, Open-label, Single and Multiple Oral Dose Study to Assess Safety and Pharmacokinetics of LHT344 in Chinese Healthy Subjects”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: October 2006
Interventions
- Drug: LHT344
Clinical Trial Outcome Measures
Primary Measures
- Pharmacokinetics of single and repeat daily oral dose of LHT344 in Chinese healthy subjects
Secondary Measures
- Safety of single and repeat daily oral dose of LHT344 in Chinese healthy subjects
Participating in This Clinical Trial
Inclusion Criteria
- 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 Criteria:
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Novartis
- Overall Official(s)
- Novartis, Principal Investigator, Investigator site
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.