Status:
COMPLETED
Study to Assess the Absorption, Distribution, Metabolism and Excretion of AZD1656 in Type 2 Diabetes Mellitus (T2DM)
Lead Sponsor:
AstraZeneca
Conditions:
Type II Diabetes Mellitus
Eligibility:
MALE
35-65 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate the absorption, distribution, metabolism and excretion of AZD1656 after administration of a single oral dose of 14C-labelled AZD1656 solution in male Type 2 Dia...
Eligibility Criteria
Inclusion
- Male type II diabetes patients diagnosed for more than 5 years and aged between 35 and 65 years.
- Subjects treated with metformin alone or metformin and one other oral anti-diabetic drug.
- Subjects should have FPG in the range of 6.0 to 11.0 mmol/L at screening and HbA1c less than 10% (HbA1c value according to international DCCT standard).
Exclusion
- History of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease.
- Renal dysfunction.
- Use of insulin, glitazones, warfarin and amiodarone within 3 months before enrolment and use of potent CYP450 inhibitors, e.g., ketoconazole and macrolide antibiotics within 14 days before administration of IP.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00960791
Start Date
July 1 2009
End Date
September 1 2009
Last Update
September 16 2009
Active Locations (2)
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1
Research Site
San Diego, California, United States
2
Research Site
San Antonio, Texas, United States