Pharmacokinetics and Pharmacodynamics Study of Saxagliptin in Healthy Subjects

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

To characterize the steady-state pharmacokinetics (PK) of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects

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

Details

• Lead Sponsor: AstraZeneca
• Treatments: Saxagliptin

Criteria

Inclusion Criteria:

• Men and women ages 18 to 45 inclusive

• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

• Body Mass Index (BMI) of 18 to 32 kg/m², inclusive. BMI = weight (kg)/ [height (m)]²

Exclusion Criteria:

• WOCBP who are unwilling or unable to use acceptable barrier methods (condoms and spermicides) to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product

• Any significant acute or chronic medical illness

• Current or recent (within 3 months) gastrointestinal disease

• Any major surgery within 4 weeks of study drug administration

• History of allergy to DPP4 inhibitor or related compounds

• Prior exposure to saxagliptin