Pharmacokinetics and Pharmacodynamics Study of Saxagliptin in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00935467
First received: July 8, 2009
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Saxagliptin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Study to Characterize the Steady-State Pharmacokinetics and Pharmacodynamics of 2.5 mg Saxagliptin Administered Twice Daily With Meals to Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Evidence of steady-state pharmacokinetics (PK) of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects [ Time Frame: Within the first 24 hours of dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To characterize the steady-state pharmacodynamics of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects [ Time Frame: 18 time points up to 14 hours on two separate study days ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 21 time points up to 23 hours after first dosing ] [ Designated as safety issue: No ]
  • To assess the safety and tolerability of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects [ Time Frame: Day 1 to Day 7 ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: July 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Saxagliptin Drug: Saxagliptin
Tablets, oral, 2.5 mg, twice daily, 7 days
Other Name: Onglyza™

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00935467

Locations
United States, Texas
Ppd Development, Lp
Austin, Texas, United States, 78744
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00935467     History of Changes
Other Study ID Numbers: CV181-091
Study First Received: July 8, 2009
Last Updated: March 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014