Safety, Tolerability, Effect of Vildagliptin and How the Body Changes the Blood Level of Vildagliptin in Healthy Chinese Volunteers

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00419887
First received: January 8, 2007
Last updated: June 21, 2007
Last verified: June 2007
  Purpose

The purpose of this study is to assess the safety, tolerability, effect of vildagliptin and how the body changes the blood level of vildagliptin of single and multiple oral doses of vildagliptin in healthy Chinese volunteers.


Condition Intervention Phase
Healthy
Drug: Vildagliptin (LAF237)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Time-Lagged, Parallel-Group, Ascending Single and Multiple Oral Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LAF237 in Chinese Healthy Subjects

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety and tolerability of single dose of vildagliptin in healthy Chinese volunteers at four sequentially ascending dose levels
  • Safety and tolerability of repeated doses of vildagliptin in healthy Chinese volunteers at five sequentially ascending dose levels
  • Pharmacokinetics and pharmacodynamics of vildagliptin in healthy Chinese volunteers at five sequentially ascending dose levels

Secondary Outcome Measures:
  • Pharmacokinetic/pharmacodynamic relationship in healthy Chinese volunteers

Estimated Enrollment: 60
Study Start Date: September 2006
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Chinese healthy volunteers age 18 to 45 years of age included
  • In good health as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation
  • All subjects must have both parents of Chinese origin and citizenship and must have been born in China.
  • Body mass index (BMI) within the range of 19 to 24 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

  • Smokers
  • Use of any prescription drugs within four (4) weeks prior dosing, or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements) within two (2) weeks prior to dosing. Paracetamol (or equivalent in China) is acceptable
  • Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
  • Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
  • Significant illness within two weeks prior to dosing.
  • A past personal or close family medical history of clinically significant cardiac abnormalities
  • History of Acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease) Clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis) Known hypersensitivity or severe adverse event to darifenacin or similar drugs Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize 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 dosing.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419887

Locations
China
Novartis
Beijing, China
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigator site
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00419887     History of Changes
Other Study ID Numbers: CLAF237A2109
Study First Received: January 8, 2007
Last Updated: June 21, 2007
Health Authority: China: Food and Drug Administration

Keywords provided by Novartis:
Safety, tolerability, pharmacokinetics, pharmacodynamics, LAF237, vildagliptin, Chinese, healthy volunteers

Additional relevant MeSH terms:
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on October 22, 2014