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OpenTrials
Completed

NCT Number: NCT00770302

Assess Pharmacokinetics, Safety and Tolerability in Healthy Chinese Volunteers After Oral Doses of Saxagliptin

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This Phase I study is designed to assess the pharmacokinetics of saxagliptin and its pharmacologically active metabolite, BMS-510849, following single and multiple oral doses of 5 mg saxagliptin in healthy Chinese subjects.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women (not of childbearing potential) of Chinese ethnicity
  • Weigh at least 50 kg and have a body mass index (BMI) between 19 and 24 kg/m2
  • Must have normal physical examination, laboratory values, ECG, pulse and blood pressure unless the investigator considers an abnormality to not be clinically significant.

Exclusion criteria

  • History of clinically significant hypoglycaemia (low blood sugar levels)
  • Women who are pregnant or breastfeeding

Treatment and study plan

Saxagliptin

Drug

Oral tablet, once daily for 1 (single-dose) and 5 (multiple-dose) days

Other names: ONGLYZA™

Primary outcomes

  1. Pharmacokinetic variables for saxagliptin after single and multiple oral doses of 5 mg saxagliptin

    Time frame: Multiple timepoints during 9 days

Secondary outcomes

  1. Pharmacokinetic variables for saxagliptin's active metabolite BMS-510849 after single and multiple oral doses of 5 mg saxagliptin

    Time frame: Multiple time points during 9 days

  2. Safety variables (adverse events reported, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests after single and multiple oral doses of 5 mg saxagliptin

    Time frame: Multiple time points during 10 days (including measurements before dosing)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

An Open Label, Pharmacokinetic Study of Single and Multiple Doses of 5 mg Saxagliptin in Healthy Chinese Subjects Living in China

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Oct 9, 2008
Registry last updated
Jul 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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