A Relative Bioavailability Study Measuring the Extent and Rate of Absorption of Different Tablet Formulations of AZD1656 in Type 2 Diabetes Mellitus (T2DM) Patients

NCT ID: NCT01221519

Last Updated: 2012-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-01-31

Brief Summary

The purpose of this study is to assess the relative bioavailability by measuring the extent and rate of absorption of different tablet formulations of AZD1656 in T2DM patients.

Conditions

Type 2 Diabetes Mellitus; High Blood Sugar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

1

AZD1656

Group Type: EXPERIMENTAL

AZD1656

Intervention Type: DRUG

3 different formulations, A, B and C of AZD1656 assessed before food intake and formulation B also after food intake

2

AZD1656

Group Type: EXPERIMENTAL

AZD1656

Intervention Type: DRUG

3 different formulations, A, B and C of AZD1656 assessed before food intake and formulation B also after food intake

3

AZD1656

Group Type: EXPERIMENTAL

AZD1656

Intervention Type: DRUG

3 different formulations, A, B and C of AZD1656 assessed before food intake and formulation B also after food intake

Interventions

AZD1656

3 different formulations, A, B and C of AZD1656 assessed before food intake and formulation B also after food intake

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Provision of signed and dated, written informed consent prior to any study specific procedures.
• Males or females of non-childbearing potential (post-menopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/ tubal ligation) aged ≥18 years. Females will be defined as post-menopausal if last menstruation period was >1 year ago and serum follicle stimulating hormone (FSH) is within the post-menopausal range, or if age >50 years and with last menstruation period >2 years ago.
• A confirmed clinical diagnosis of T2DM for at least 1 year, treated with metformin as a single treatment or in combination with one other oral anti-diabetic (ie, DPPIV inhibitor or SU) for at least 2 months prior to screening. Doses of anti-diabetic treatment should have been stable for at least 1 month prior to screening.
• Treatment with at least 1000mg of Metformin for 2 months and being stable on the Metformin Therapy for 1 month
• Hb A1c >6.5% (international standard) at enrolment.
• Body mass index (BMI) between ≥19 and ≤42 kg/m2.

Exclusion Criteria

• Clinically significant illness or clinically relevant trauma, as judged by the Investigator, within 2 weeks prior to the first administration of AZD1656
• Participation in another clinical study during the 30 days prior to screening or intake of another investigational drug within 30 days (or at least 5 x t1/2 of the drug) prior to the first administration of AZD1656.
• History of, or ongoing, ischemic heart disease or heart failure. Stroke, transitory ischemic attack, or symptomatic peripheral arterial disease within the last 6 months.
• Clinically significant abnormalities in ECG, clinical chemistry, hematology or urinalysis results.
• Positive test for Hepatitis B surface antigen (HBsAg) or antibodies to human immunodeficiency virus (HIV) or Hepatitis C virus.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva Johnsson, MD, PhD

Role: STUDY_DIRECTOR

AstraZeneca Sweden

Mark Matson, MD

Role: PRINCIPAL_INVESTIGATOR

Prism Research

Mirjana Kujacic Kujacic, MD, PhD

Role: STUDY_CHAIR

AstraZeneca R&D Mölndal

Locations

Research Site

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

D1020C00033

Identifier Type: -

Identifier Source: org_study_id