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

Type 2 Diabetes Clinical Trial

Official title:

An Open Label, Pharmacokinetic Study of Single and Multiple Doses of 5 mg Saxagliptin in Healthy Chinese Subjects Living in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770302
• Other study ID #: D1680C00004
• Status: Completed
• Phase: Phase 1
• First received: October 8, 2008
• Last updated: July 8, 2009
• Start date: October 2008
• Est. completion date: October 2008

Study information

• Verified date: July 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• Saxagliptin
Oral tablet, once daily for 1 (single-dose) and 5 (multiple-dose) days

Locations

Country	Name	City	State
China	Research Site	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic variables for saxagliptin after single and multiple oral doses of 5 mg saxagliptin		Multiple timepoints during 9 days	No
Secondary	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	No
Secondary	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)	Yes