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

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ClinicalTrials.gov Identifier: NCT00770302
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : July 9, 2009
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Saxagliptin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

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


Intervention Details:
    Drug: Saxagliptin
    Oral tablet, once daily for 1 (single-dose) and 5 (multiple-dose) days
    Other Name: ONGLYZA™


Primary Outcome Measures :
  1. Pharmacokinetic variables for saxagliptin after single and multiple oral doses of 5 mg saxagliptin [ Time Frame: Multiple timepoints during 9 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 9, 2008    Key Record Dates
Last Update Posted: July 9, 2009
Last Verified: July 2009

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

Additional relevant MeSH terms:
Saxagliptin
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents