Pharmacokinetics and Pharmacodynamics Study of Saxagliptin in Healthy Subjects

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Saxagliptin

• Registration Number: NCT00935467
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-08
• Study First Submitted QC: 2009-07-08
• Study First Posted: 2009-07-09
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-04
• Last Update Posted: 2015-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Saxagliptin	Saxagliptin	-

Primary Outcome Measures

Name	Time	Method
Evidence of steady-state pharmacokinetics (PK) of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects	Within the first 24 hours of dosing

Secondary Outcome Measures

Name	Time	Method
To assess the PK of the pharmacologically active major metabolite of saxagliptin, BMS-510849, following administration of 2.5 mg saxagliptin twice daily with meals to healthy subjects	21 time points up to 23 hours after first dosing
To assess the safety and tolerability of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects	Day 1 to Day 7
To characterize the steady-state pharmacodynamics of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects	18 time points up to 14 hours on two separate study days

Trial Locations

Locations (1)

Ppd Development, Lp; 🇺🇸 Austin, Texas, United States