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

Novartis1 site in 1 country12 target enrollmentOctober 2006

ConditionsHealthy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy
Sponsor: Novartis
Enrollment: 12
Locations: 1
Primary Endpoint: Pharmacokinetics of single and repeat daily oral dose of LHT344 in Chinese healthy subjects
Status: Completed
Last Updated: 15 years ago

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.

Registry

clinicaltrials.gov

Start Date

October 2006

End Date

October 2006

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

•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

•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