Status:
COMPLETED
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics After High Single Ascending Oral Doses of AZD1656 in T2DM Patients
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
MALE
20-60 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate safety and tolerability after high Single Ascending Oral Doses of AZD1656.
Eligibility Criteria
Inclusion
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Male, T2DM patients aged 20-60 years
- Treatment with 1 to 2 OADs as Therapy for T2DM for at least 30 days prior to enrollment
- Patients should not have been treated with glitazones within 6 months prior to enrollment
- Male T2DM patients without known cardiovascular disease, with the exception of Grade 1 hypertension without secondary organ involvement (eg. grade 1 HT is allowed if no eye, kidney disease or LVH has been documented).
Exclusion
- History of ischemic heart disease , heart failure, stroke, transitory ischemic attack or peripheral vascular disease.
- Prolonged QTcF\>450 msec or shortened QTcF\<350 msec or family history of long QT syndrome.
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
- Systolic BP\>159 mmHg or diastolic BP\>99 mmHg at screening and on Day-1
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01221545
Start Date
October 1 2010
End Date
January 1 2011
Last Update
February 17 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Chula Vista, California, United States