- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00960791
Study to Assess the Absorption, Distribution, Metabolism and Excretion of AZD1656 in Type 2 Diabetes Mellitus (T2DM) (ADME)
September 15, 2009 updated by: AstraZeneca
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
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States
- Research Site
-
-
Texas
-
San Antonio, Texas, United States
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
14C-labelled AZD1656
|
Oral single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
Outcome Measure |
Time Frame |
---|---|
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
|
Frequent measurements during the study period
|
Plasma Glucose
Time Frame: Plasma Glucose will be measured twice daily during residential period
|
Plasma Glucose will be measured twice daily during residential period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion
December 7, 2022
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
August 17, 2009
First Submitted That Met QC Criteria
August 17, 2009
First Posted (Estimate)
August 18, 2009
Study Record Updates
Last Update Posted (Estimate)
September 16, 2009
Last Update Submitted That Met QC Criteria
September 15, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1020C00008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type II Diabetes Mellitus
-
pico-tesla Magnetic Therapies, LLCCompletedType II Diabetes MellitusUnited States
-
Medical College of WisconsinMedical University of South CarolinaCompletedDiabetes Mellitus | Type 2 Diabetes Mellitus | Adult-Onset Diabetes Mellitus | Non-Insulin-Dependent Diabetes Mellitus | Noninsulin Dependent Diabetes Mellitus, Type IIUnited States
-
KeyBioscience AGEli Lilly and Company; Profil Institut für Stoffwechselforschung GmbH; Nordic...TerminatedType II Diabetes MellitusGermany
-
HealthInsightCenter for Technology and Aging; VoxivaUnknownType II Diabetes MellitusUnited States
-
University of PretoriaNestlè Nutrition Institute Africa; South African Sugar AssociationCompletedDiabetes Mellitus, Type II [Non-insulin Dependent Type] [NIDDM Type] UncontrolledSouth Africa
-
Microbio Co LtdCompleted
-
University of PrimorskaUniversity of Ljubljana School of Medicine, SloveniaCompletedDiabetes Mellitus Type II,Slovenia
-
Laboratorios Silanes S.A. de C.V.RecruitingDyslipidemia Associated With Type II Diabetes MellitusMexico
-
Assiut UniversityNot yet recruitingDyslipidemia Associated With Type II Diabetes Mellitus
Clinical Trials on AZD1656
-
AstraZenecaCompleted
-
AstraZenecaCompleted
-
AstraZenecaCompleted
-
AstraZenecaCompletedGlucose LoweringUnited States
-
AstraZenecaCompletedHealthy VolunteersUnited States
-
St George Street CapitalCompletedCovid19Czechia, Romania, United Kingdom
-
AstraZenecaCompleted
-
Queen Mary University of LondonAstraZenecaActive, not recruitingDiabetes Mellitus, Type 2 | End Stage Renal Disease | Type 2 Diabetes | Renal Transplant | Kidney Transplant; ComplicationsUnited Kingdom
-
AstraZenecaCompletedType 2 Diabetes MellitusJapan
-
AstraZenecaCompletedType 2 Diabetes MellitusUnited States