Safety and Pharmacokinetics of LHT344 in Chinese Healthy Subjects

Novartis

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LHT344

Study type: Interventional

Funder types: Industry

Identifiers

NCT00414778

CLHT344A2101

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)