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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

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

35 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

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

NCT ID

NCT00960791

First Posted

August 17, 2009

Last Updated

September 15, 2009

Sponsor

AstraZeneca

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

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

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

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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