Single ascending dose study with healthy male volunteers and type II diabetic patients
Study identifier:D1920C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A Randomised, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Interaction after Single Ascending Oral Doses of AZD6714 in Healthy Male volunteers and Male Type II Diabetic Patients
Medical condition
Type 2 Diabetes
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD6714, Placebo
Sex
All
Actual Enrollment
26
Study type
Interventional
Age
20 Years - 40 Years
Date
Study Start Date: 01 Apr 2009
Primary Completion Date: 01 Sept 2009
Study Completion Date: 01 Sept 2009
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 Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD6714 in 8 increasing oral single doses a-h given to 8 groups (3 on active and 1 on placebo in each group) | Drug: AZD6714 Oral single doses a-h suspension Drug: Placebo Oral single doses suspension |
| Experimental: 2 2 oral single doses d and g suspensions of AZD6714 given to 2 groups (3+1) together with food | Drug: Placebo Oral single doses suspension Drug: AZD6714 Oral single doses d and g suspension |
| Experimental: 3 Two increasing oral doses of AZD6714 and one placebo given to 2 groups with 3 type 2 diabetic patients. | Drug: Placebo Oral single doses suspension Drug: AZD6714 Oral single doses a-d suspension |
Contacts
Investigators
Principal Investigator
Klas Malmberg
AstraZeneca R&D Mölndal
