Safety and Pharmacokinetics of LHT344 in Chinese Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00414778
First received: December 21, 2006
Last updated: January 12, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Healthy
Drug: LHT344
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Novartis:

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

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

Enrollment: 12
Study Start Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414778

Locations
China
Novartis Investigative Site
Beijing, China
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigator site
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00414778     History of Changes
Other Study ID Numbers: CLHT344A2101
Study First Received: December 21, 2006
Last Updated: January 12, 2011
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014