Clinical trial NCT00414778: Safety and Pharmacokinetics of LHT344 in Chinese Healthy Subjects
Official title: A Single-center, Open-label, Single and Multiple Oral Dose Study to Assess Safety and Pharmacokinetics of LHT344 in Chinese Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety, pharmacokinetics, oral, single dose, multiple dose, LHT344, Chinese, healthy subjects
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Pharmacokinetics of single and repeat daily oral dose of LHT344 in Chinese healthy subjects
Secondary outcomes:
measure: Safety of single and repeat daily oral dose of LHT344 in Chinese healthy subjects
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novartis Investigative Site
Study officials:
affiliation: Investigator site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References: