Study to Assess the Absorption, Distribution, Metabolism and Excretion of AZD1656 in Type 2 Diabetes Mellitus (T2DM)
Phase 1
Completed
- Conditions
- Type II Diabetes Mellitus
- Interventions
- Device: AZD1656
- Registration Number
- NCT00960791
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 AZD1656 14C-labelled AZD1656
- Primary Outcome Measures
Name Time Method 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) 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
Name Time Method Safety variables: Adverse Events (AEs), Blood pressure (BP), pulse, ECG and safety laboratory variables, glucose quick test Frequent measurements during the study period Plasma Glucose Plasma Glucose will be measured twice daily during residential period
Trial Locations
- Locations (1)
Research Site
🇺🇸San Antonio, Texas, United States