Study to Assess the Absorption, Distribution, Metabolism and Excretion of AZD1656 in Type 2 Diabetes Mellitus (T2DM) (ADME)

September 15, 2009 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Diego, California, United States
        • Research Site
    • Texas
      • San Antonio, Texas, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
14C-labelled AZD1656
Oral single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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 Measures

Outcome Measure
Time Frame
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
Frequent measurements during the study period
Plasma Glucose
Time Frame: Plasma Glucose will be measured twice daily during residential period
Plasma Glucose will be measured twice daily during residential period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Klas Malmberg, MD, PhD, Prof.,, AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden
  • Principal Investigator: Emeline Ramos, MD, Clinical Pharmacology Unit (CPU)AstraZeneca R&D Alderley ParkMacclesfield, Cheshire SK10 4TG, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion

December 7, 2022

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

August 17, 2009

First Submitted That Met QC Criteria

August 17, 2009

First Posted (Estimate)

August 18, 2009

Study Record Updates

Last Update Posted (Estimate)

September 16, 2009

Last Update Submitted That Met QC Criteria

September 15, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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