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

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Bristol-Myers Squibb
• Treatments: Saxagliptin

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