Study to Assess the Absorption, Distribution, Metabolism and Excretion of AZD1656 in Type 2 Diabetes Mellitus (T2DM) (ADME)
Primary Purpose
Type II Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AZD1656
Sponsored by
About this trial
This is an interventional treatment trial for Type II Diabetes Mellitus focused on measuring Type II diabetes mellitus, absorption, distribution, metabolism, excretion, 14C-labelled
Eligibility Criteria
Inclusion Criteria:
- Male type II diabetes patients diagnosed for more than 5 years and aged between 35 and 65 years.
- Subjects treated with metformin alone or metformin and one other oral anti-diabetic drug.
- Subjects should have FPG in the range of 6.0 to 11.0 mmol/L at screening and HbA1c less than 10% (HbA1c value according to international DCCT standard).
Exclusion Criteria:
- History of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease.
- Renal dysfunction.
- Use of insulin, glitazones, warfarin and amiodarone within 3 months before enrolment and use of potent CYP450 inhibitors, e.g., ketoconazole and macrolide antibiotics within 14 days before administration of IP.
Sites / Locations
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
14C-labelled AZD1656
Outcomes
Primary Outcome Measures
Total recovery of radioactive dose, rate and routes of excretion of total radioactivity, metabolic pattern and metabolic profile, and PK variables of AZD1656 (AUC, Cmax, tmax, t1/2, Total Ae, CL/F and CLR)
Secondary Outcome Measures
Safety variables: Adverse Events (AEs), Blood pressure (BP), pulse, ECG and safety laboratory variables, glucose quick test
Plasma Glucose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00960791
Brief Title
Study to Assess the Absorption, Distribution, Metabolism and Excretion of AZD1656 in Type 2 Diabetes Mellitus (T2DM)
Acronym
ADME
Official Title
An Open, Single-centre, Single Group, Phase I Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of AZD1656 After Oral Administration of 14C-labelled AZD1656 to Type II Diabetes Mellitus Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to evaluate the absorption, distribution, metabolism and excretion of AZD1656 after administration of a single oral dose of 14C-labelled AZD1656 solution in male Type 2 Diabetes Mellitus patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes Mellitus
Keywords
Type II diabetes mellitus, absorption, distribution, metabolism, excretion, 14C-labelled
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
14C-labelled AZD1656
Intervention Type
Device
Intervention Name(s)
AZD1656
Intervention Description
Oral single dose
Primary Outcome Measure Information:
Title
Total recovery of radioactive dose, rate and routes of excretion of total radioactivity, metabolic pattern and metabolic profile, and PK variables of AZD1656 (AUC, Cmax, tmax, t1/2, Total Ae, CL/F and CLR)
Time Frame
One blood sample for analysis of plasma concentrations of AZD1656 taken on several days during the treatment period. A full PK profile for AZD1656 will also be taken on the last day of treatment
Secondary Outcome Measure Information:
Title
Safety variables: Adverse Events (AEs), Blood pressure (BP), pulse, ECG and safety laboratory variables, glucose quick test
Time Frame
Frequent measurements during the study period
Title
Plasma Glucose
Time Frame
Plasma Glucose will be measured twice daily during residential period
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male type II diabetes patients diagnosed for more than 5 years and aged between 35 and 65 years.
Subjects treated with metformin alone or metformin and one other oral anti-diabetic drug.
Subjects should have FPG in the range of 6.0 to 11.0 mmol/L at screening and HbA1c less than 10% (HbA1c value according to international DCCT standard).
Exclusion Criteria:
History of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease.
Renal dysfunction.
Use of insulin, glitazones, warfarin and amiodarone within 3 months before enrolment and use of potent CYP450 inhibitors, e.g., ketoconazole and macrolide antibiotics within 14 days before administration of IP.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klas Malmberg, MD, PhD, Prof.,
Organizational Affiliation
AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Emeline Ramos, MD
Organizational Affiliation
Clinical Pharmacology Unit (CPU)AstraZeneca R&D Alderley ParkMacclesfield, Cheshire SK10 4TG, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Assess the Absorption, Distribution, Metabolism and Excretion of AZD1656 in Type 2 Diabetes Mellitus (T2DM)
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