Safety and Pharmacokinetics of LHT344 in Chinese Healthy Subjects

Novartis logo

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)

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems