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

AstraZeneca34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

SaxagliptinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Beijing, China

Outcomes

Primary Outcomes

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

Time frame: Multiple timepoints during 9 days

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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