Status:
COMPLETED
To Assess Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Effect of Fasting After Single Oral Doses of AZD5658 in Type 2 Diabetes
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
20-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the safety and tolerability of AZD5658 following ascending single oral doses in Type 2 Diabetics. It will also estimate the maximum tolerated dose.
Detailed Description
This is a randomized, single-blind, placebo-controlled, single-center, phase 1 study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and the effect of fasting after single ascen...
Eligibility Criteria
Inclusion
- Patients must be of non-childbearing potential.
- Body mass index between greater than or equal to 19 and less than or equal to 40 kg/m2
- Patients with confirmed Type 2 Diabetes diagnosis for at least 1 year and treated with Metformin
Exclusion
- Clinically significant illness or clinically relevant trauma within 2 weeks before the first administration of the IP
- Participation in another clinical study during the last 30 days prior to enrollment
- Significant cardiovascular event within the last 6 months prior to enrollment
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01176097
Start Date
July 1 2010
End Date
February 1 2011
Last Update
February 2 2012
Active Locations (1)
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1
Research Site
Chula Vista, California, United States