Pharmacokinetics and Pharmacodynamics Study of Saxagliptin in Healthy Subjects

A Study to Characterize the Steady-State Pharmacokinetics and Pharmacodynamics of 2.5 mg Saxagliptin Administered Twice Daily With Meals to Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00935467

Enrollment

Registered

2009-07-09

Start date

2009-07-31

Completion date

2009-08-31

Last updated

2015-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

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

Interventions

DRUGSaxagliptin

Tablets, oral, 2.5 mg, twice daily, 7 days

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026