Pharmacokinetics and Pharmacodynamics Study of Saxagliptin in Healthy Subjects

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Saxagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00935467

CV181-091

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

12 participants in 1 patient group

Saxagliptin

Other group

Treatment:

Drug: Saxagliptin