To assess safety, tolerability, Pharmacokinetics/Pharmacodynamics and the effect of fasting after single oral doses of AZD5658 in Type 2 Diabetes
Study identifier:D2920C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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 Ascending Oral Doses of AZD5658 in Type 2 Diabetes Mellitus Patients
Medical condition
Type 2 Diabetes
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD5658, Placebo
Sex
All
Actual Enrollment
24
Study type
Interventional
Age
20 Years - 65 Years
Date
Study Start Date: 01 Jul 2010
Primary Completion Date: 01 Feb 2011
Study Completion Date: 01 Feb 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 6 - 8 cohorts 6 patients in each cohort will receive AZD5658 | Drug: AZD5658 oral suspension, escalating single doses |
| Placebo Comparator: 6 - 8 cohorts 2 patients in each cohort will receive placebo | Drug: Placebo oral suspension,single doses |
Contacts
Investigators
Principal Investigator
Karin Wahlander
AstraZeneca R&DPepparedsleden 1431 83 M�lnda
