Safety and Pharmacokinetics of LHT344 in Chinese Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Single-center, Open-label, Single and Multiple Oral Dose Study to Assess Safety and Pharmacokinetics of LHT344 in Chinese Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LHT344


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LHT344|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of single and repeat daily oral dose of LHT344 in Chinese healthy subjects |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of single and repeat daily oral dose of LHT344 in Chinese healthy subjects |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, pharmacokinetics, oral, single dose, multiple dose, LHT344, Chinese, healthy subjects