Assess Pharmacokinetics, Safety and Tolerability in Healthy Chinese Volunteers After Oral Doses of Saxagliptin
An Open Label, Pharmacokinetic Study of Single and Multiple Doses of 5 mg Saxagliptin in Healthy Chinese Subjects Living in China
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes
Started Oct 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 8, 2008
CompletedFirst Posted
Study publicly available on registry
October 9, 2008
CompletedJuly 9, 2009
July 1, 2009
Same day
October 8, 2008
July 8, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic variables for saxagliptin after single and multiple oral doses of 5 mg saxagliptin
Multiple timepoints during 9 days
Secondary Outcomes (2)
Pharmacokinetic variables for saxagliptin's active metabolite BMS-510849 after single and multiple oral doses of 5 mg saxagliptin
Multiple time points during 9 days
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
Multiple time points during 10 days (including measurements before dosing)
Interventions
Oral tablet, once daily for 1 (single-dose) and 5 (multiple-dose) days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- History of clinically significant hypoglycaemia (low blood sugar levels)
- Women who are pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (1)
Research Site
Beijing, China
Related Publications (1)
Li H, Yang L, Tou CK, Patel CG, Zhao J. Pharmacokinetic study of saxagliptin in healthy Chinese subjects. Clin Drug Investig. 2012 Jul 1;32(7):465-73. doi: 10.2165/11598760-000000000-00000.
PMID: 22668067DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Peter Öhman, MD, PhD
AstraZeneca
- STUDY CHAIR
Deborah Price, MSc
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 8, 2008
First Posted
October 9, 2008
Study Start
October 1, 2008
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
July 9, 2009
Record last verified: 2009-07