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

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