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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014