Status:
TERMINATED
Single Ascending Dose Study With Healthy Male Volunteers and Type II Diabetic Patients
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
20-40 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess safety and tolerability of AZD6714 after single ascending oral doses in healthy male subjects and type 2 diabetic patients.
Eligibility Criteria
Inclusion
- Part A,Healthy male subjects, aged between ≥20 and ≤40 years.
- Part B,Male T2DM patients, aged between ≥20 and ≤65 years. Treatment with metformin as single therapy for T2DM for at least 30 days prior to enrollment
Exclusion
- Part A,Clin sign illness or clin relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the IP.
- Part A Clin sign abnormalities in clinical chemistry, haematology, or urinalysis results as judged by the investigator
- Part B, History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease.
- Any clinically significant abnormality identified on physical examination, laboratory tests or ECG, which in the judgment of the investigator would compromise the patient's safety or successful participation.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00886366
Start Date
April 1 2009
End Date
September 1 2009
Last Update
December 7 2010
Active Locations (1)
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1
Research Site
Gothenburg, Sweden