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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
History of Changes
  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:

Drug Information available for: Saxagliptin
U.S. FDA Resources

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
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 May 16, 2013