A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics after high Single Ascending Oral Doses of AZD1656 in T2DM Patients
Study identifier:D1020C00044
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomised, Single-Blind, Placebo-Controlled, Single-Centre Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics after high Single Ascending Oral Supratherapeutic Doses of AZD1656 in Male Type 2 Diabetes Mellitus (T2DM) Patients
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD1656, Placebo
Sex
Male
Actual Enrollment
24
Study type
Interventional
Age
20 Years - 60 Years
Date
Study Start Date: 01 Oct 2010
Primary Completion Date: 01 Jan 2011
Study Completion Date: 01 Jan 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: A - AZD1656 AZD1656 | Drug: AZD1656 3 escalating dose levels are planned. Administration of the escalating doses of AZD1656 will be based on review of available safety from the previous dose. Other Name: AZD1656 |
| Placebo Comparator: B - Placebo Placebo | Drug: Placebo Placebo Other Name: Placebo |
Contacts
Investigators
Principal Investigator
Linda Morrow
Profil Institute for Clinical Research, Inc.
