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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00770302
• Date of registration: 08/10/2008
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: Assess Pharmacokinetics, Safety and Tolerability in Healthy Chinese Volunteers After Oral Doses of Saxagliptin
• Scientific title: An Open Label, Pharmacokinetic Study of Single and Multiple Doses of 5 mg Saxagliptin in Healthy Chinese Subjects Living in China
• Date of first enrolment: October 2008
• Target sample size: 34
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00770302
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 1

Countries of recruitment

China

Contacts

• Name: Peter Öhman, MD, PhD
• Affiliation: AstraZeneca

• Name: Deborah Price, MSc
• Affiliation: AstraZeneca

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 Diabetes

Intervention(s)

Drug: Saxagliptin

Primary Outcome(s)

Pharmacokinetic variables for saxagliptin after single and multiple oral doses of 5 mg saxagliptin [Time Frame: Multiple timepoints during 9 days]

Secondary Outcome(s)

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]

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)]

Secondary ID(s)

D1680C00004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb