Study to Assess the Absorption, Distribution, Metabolism and Excretion of AZD1656 in Type 2 Diabetes Mellitus (T2DM)
ADME
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
1 other identifier
interventional
6
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2009
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 17, 2009
CompletedFirst Posted
Study publicly available on registry
August 18, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedSeptember 16, 2009
September 1, 2009
August 17, 2009
September 15, 2009
Conditions
Keywords
Outcome Measures
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)
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 (2)
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
Study Arms (1)
1
EXPERIMENTAL14C-labelled AZD1656
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (2)
Research Site
San Diego, California, United States
Research Site
San Antonio, Texas, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 17, 2009
First Posted
August 18, 2009
Study Start
July 1, 2009
Study Completion
September 1, 2009
Last Updated
September 16, 2009
Record last verified: 2009-09