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Safety and Pharmacokinetics of LHT344 in Chinese Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00414778
Recruitment Status : Completed
First Posted : December 22, 2006
Last Update Posted : January 13, 2011
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: LHT344 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-center, Open-label, Single and Multiple Oral Dose Study to Assess Safety and Pharmacokinetics of LHT344 in Chinese Healthy Subjects
Study Start Date : October 2006
Primary Completion Date : October 2006

Primary Outcome Measures :
  1. Pharmacokinetics of single and repeat daily oral dose of LHT344 in Chinese healthy subjects

Secondary Outcome Measures :
  1. Safety of single and repeat daily oral dose of LHT344 in Chinese healthy subjects

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414778

Novartis Investigative Site
Beijing, China
Sponsors and Collaborators
Principal Investigator: Novartis Investigator site

ClinicalTrials.gov Identifier: NCT00414778     History of Changes
Other Study ID Numbers: CLHT344A2101
First Posted: December 22, 2006    Key Record Dates
Last Update Posted: January 13, 2011
Last Verified: January 2011

Keywords provided by Novartis:
Safety, pharmacokinetics, oral, single dose, multiple dose, LHT344, Chinese, healthy subjects