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

NCT01221519 | Completed Phase 1

• 1 other identifier: D1020C00033
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Phase I; Bioavailability; Type 2 Diabetes Mellitus; Diabetic treatment; Metformin; High blood sugar

Outcome Measures

Primary Outcomes (12)

• Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656.

  Blood samples will be collected from predose to 48 hrs at each treatment period 1

• Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of Cmax of AZD1656.

  Blood samples will be collected from predose to 48 hrs at each treatment period 1

• Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of tmax of AZD1656.

  Blood samples will be collected from predose to 48 hrs at each treatment period 1

• Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656.

  Blood samples will be collected from predose to 48 hrs at each treatment period 2

• Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of Cmax of AZD1656.

  Blood samples will be collected from predose to 48 hrs at each treatment period 2

• Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of tmax of AZD1656.

  Blood samples will be collected from predose to 48 hrs at each treatment period 2

• Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656.

  Blood samples will be collected from predose to 48 hrs at each treatment period 3

• Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of Cmax of AZD1656.

  Blood samples will be collected from predose to 48 hrs at each treatment period 3

• Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of tmax of AZD1656.

  Blood samples will be collected from predose to 48 hrs at each treatment period 3

• Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656.

  Blood samples will be collected from predose to 48 hrs at each treatment period 4

• Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of Cmax of AZD1656.

  Blood samples will be collected from predose to 48 hrs at each treatment period 4

• Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of tmax of AZD1656.

  Blood samples will be collected from predose to 48 hrs at each treatment period 4

Secondary Outcomes (23)

• To evaluate the safety of AZD1656 by assessing a panel of adverse events measures: physical examination, electrocardiogram, pulse and blood pressure, weight and laboratory, variables including plasma glucose.

  start of treatment until follow up

• Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC

  PK blood samples will be collected from predose to 48 hrs after each treatment period 1

• Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-t).

  PK blood samples will be collected from predose to 48 hrs after each treatment period 1

• Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of Cmax.

  PK blood samples will be collected from predose to 48 hrs after each treatment period 1

• Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of tmax.

  PK blood samples will be collected from predose to 48 hrs after each treatment period 1

Study Arms (3)

1

EXPERIMENTAL

AZD1656

Drug: AZD1656

2

EXPERIMENTAL

AZD1656

Drug: AZD1656

3

EXPERIMENTAL

AZD1656

Drug: AZD1656

Interventions

AZD1656 DRUG

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

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Saint Paul, Minnesota, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia

Interventions

AZD1656

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Eva Johnsson, MD, PhD

  AstraZeneca Sweden

  STUDY DIRECTOR

• Mark Matson, MD

  Prism Research

  PRINCIPAL INVESTIGATOR

• Mirjana Kujacic Kujacic, MD, PhD

  AstraZeneca R&D Mölndal

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: October 15, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: January 19, 2012

Record last verified: 2012-01

Locations

US (1)