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Completed

NCT Number: NCT00960791

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

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.

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Key information

Conditions

Type II Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD1656

Device

Oral single dose

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: ADME

Important dates

Study start
2009
Study completion
2009
First posted
Aug 18, 2009
Registry last updated
Sep 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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