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

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ClinicalTrials.gov Identifier: NCT00960791
Recruitment Status : Completed
First Posted : August 18, 2009
Last Update Posted : September 16, 2009
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Type II Diabetes Mellitus Device: AZD1656 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
14C-labelled AZD1656
Device: AZD1656
Oral single dose




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. Plasma Glucose [ Time Frame: Plasma Glucose will be measured twice daily during residential period ]


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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00960791     History of Changes
Other Study ID Numbers: D1020C00008
First Posted: August 18, 2009    Key Record Dates
Last Update Posted: September 16, 2009
Last Verified: September 2009

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