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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Saxagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00770302

D1680C00004

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)