Assess Pharmacokinetics, Safety and Tolerability in Healthy Chinese Volunteers After Oral Doses of Saxagliptin

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00770302
First received: October 8, 2008
Last updated: July 8, 2009
Last verified: July 2009
  Purpose

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This Phase I study is designed to assess the pharmacokinetics of saxagliptin and its pharmacologically active metabolite, BMS-510849, following single and multiple oral doses of 5 mg saxagliptin in healthy Chinese subjects.


Condition Intervention Phase
Type 2 Diabetes
Drug: Saxagliptin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open Label, Pharmacokinetic Study of Single and Multiple Doses of 5 mg Saxagliptin in Healthy Chinese Subjects Living in China

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Pharmacokinetic variables for saxagliptin after single and multiple oral doses of 5 mg saxagliptin [ Time Frame: Multiple timepoints during 9 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic variables for saxagliptin's active metabolite BMS-510849 after single and multiple oral doses of 5 mg saxagliptin [ Time Frame: Multiple time points during 9 days ] [ Designated as safety issue: No ]
  • Safety variables (adverse events reported, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests after single and multiple oral doses of 5 mg saxagliptin [ Time Frame: Multiple time points during 10 days (including measurements before dosing) ] [ Designated as safety issue: Yes ]

Enrollment: 34
Study Start Date: October 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Saxagliptin
    Oral tablet, once daily for 1 (single-dose) and 5 (multiple-dose) days
    Other Name: ONGLYZA™
  Eligibility

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

Inclusion Criteria:

  • Men or women (not of childbearing potential) of Chinese ethnicity
  • Weigh at least 50 kg and have a body mass index (BMI) between 19 and 24 kg/m2
  • Must have normal physical examination, laboratory values, ECG, pulse and blood pressure unless the investigator considers an abnormality to not be clinically significant.

Exclusion Criteria:

  • History of clinically significant hypoglycaemia (low blood sugar levels)
  • Women who are pregnant or breastfeeding
  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: NCT00770302

Locations
China
Research Site
Beijing, China
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Director: Peter Öhman, MD, PhD AstraZeneca
Study Chair: Deborah Price, MSc AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Öhman, MD, PhD, Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00770302     History of Changes
Other Study ID Numbers: D1680C00004
Study First Received: October 8, 2008
Last Updated: July 8, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
DPP-4 inhibitors
HBA1c
Incretins
Pharmacokinetics

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014