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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type II Diabetes Mellitus

Treatments: Device: AZD1656

Study type: Interventional

Funder types: Industry

Identifiers

NCT00960791

D1020C00008

Details and patient eligibility

About

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.

Enrollment: 6 estimated patients

Sex: Male

Ages: 35 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

1

Experimental group

Description:

14C-labelled AZD1656

Treatment:

Device: AZD1656