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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00960791
First received: August 17, 2009
Last updated: September 15, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Type II Diabetes Mellitus
Device: AZD1656
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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) [ 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Plasma Glucose [ Time Frame: Plasma Glucose will be measured twice daily during residential period ] [ Designated as safety issue: No ]

Estimated Enrollment: 6
Study Start Date: July 2009
Study Completion Date: September 2009
Arms Assigned Interventions
Experimental: 1
14C-labelled AZD1656
Device: AZD1656
Oral single dose

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00960791

Locations
United States, California
Research Site
San Diego, California, United States
United States, Texas
Research Site
San Antonio, Texas, United States
Sponsors and Collaborators
AstraZeneca
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
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00960791     History of Changes
Other Study ID Numbers: D1020C00008
Study First Received: August 17, 2009
Last Updated: September 15, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Type II diabetes mellitus
absorption
distribution
metabolism
excretion
14C-labelled

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014