Safety and Pharmacokinetics of LHT344 in Chinese Healthy Subjects

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00414778
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2006-10
• Study First Submitted: 2006-12-21
• Study First Submitted QC: 2006-12-21
• Study First Posted: 2006-12-22
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-12
• Last Update Posted: 2011-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of single and repeat daily oral dose of LHT344 in Chinese healthy subjects

Secondary Outcome Measures

Name	Time	Method
Safety of single and repeat daily oral dose of LHT344 in Chinese healthy subjects

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇳 Beijing, China