Pharmacokinetics and Pharmacodynamics Study of Saxagliptin in Healthy Subjects

Completed · Phase 1

Conditions studied: Type 2 Diabetes Mellitus

In brief

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

Key facts

Study ID

NCT00935467

Run by

AstraZeneca

People needed

12

Starts

2009-07-01

Expected to finish

2009-08-01

Last updated by the study team

2015-05-05

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ppd Development, Lp — Austin, Texas, United States

Full record on ClinicalTrials.gov

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