Safety and Pharmacokinetics of LHT344 in Chinese Healthy Subjects

NCT ID: NCT00414778

Last Updated: 2011-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

LHT344

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Principal Investigators

Novartis

Role: PRINCIPAL_INVESTIGATOR

Investigator site

Locations

Novartis Investigative Site

Beijing, , China

Countries

China

Other Identifiers

CLHT344A2101

Identifier Type: -

Identifier Source: org_study_id