Healthy
Conditions
Keywords
Safety, pharmacokinetics, oral, single dose, multiple dose, LHT344, Chinese, healthy subjects
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.
Interventions
DRUGLHT344
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of single and repeat daily oral dose of LHT344 in Chinese healthy subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of single and repeat daily oral dose of LHT344 in Chinese healthy subjects | — |
Countries
China
Outcome results
None listed