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To Evaluate the Bioavailability of a Tablet of AZD1656

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AZD1656
AZD1656
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type I diabetes, bioavailability

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female, type I diabetes patients, female with non child-bearing potential.
  • Treated with insulin for more than 3 years. Well controlled HbA1c.
  • Have a body mass index (BMI) ≥19 and ≤35

Exclusion Criteria:

  • Clinically significant illness except type I diabetes, or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product
  • Daily use of nicotine containing substances.

Sites / Locations

  • Research site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

AZD1656 tablet + food

AZD1656 susp. without food

AZD1656 tablet

Outcomes

Primary Outcome Measures

Pharmacokinetic variables ( Area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal elimination half-life (t½) and apparent oral clearance (CL/F)

Secondary Outcome Measures

Pharmacodynamic variables (Plasma glucose)
Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables)

Full Information

First Posted
December 24, 2008
Last Updated
November 2, 2009
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00817505
Brief Title
To Evaluate the Bioavailability of a Tablet of AZD1656
Official Title
A Randomized, Open, Single-Dose, Single-Centre, Cross-over, Phase I Study in Type 1 Diabetes Mellitus Patients to Estimate the Extent and Rate of Absorption of AZD1656 After Administration of a Tablet Formulation in the Fasting State and Just Before Food in Comparison With an Oral Suspension of AZD1
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
To evaluate the bioavailability of a tablet of AZD1656.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type I diabetes, bioavailability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
AZD1656 tablet + food
Arm Title
2
Arm Type
Active Comparator
Arm Description
AZD1656 susp. without food
Arm Title
3
Arm Type
Active Comparator
Arm Description
AZD1656 tablet
Intervention Type
Drug
Intervention Name(s)
AZD1656
Intervention Description
Single dose oral tablet
Intervention Type
Drug
Intervention Name(s)
AZD1656
Intervention Description
Single dose oral suspension
Primary Outcome Measure Information:
Title
Pharmacokinetic variables ( Area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal elimination half-life (t½) and apparent oral clearance (CL/F)
Time Frame
Blood samples taken up to 72 hours
Secondary Outcome Measure Information:
Title
Pharmacodynamic variables (Plasma glucose)
Time Frame
Taken repeatedly during treatment periods
Title
Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables)
Time Frame
Taken during treatment periods

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, type I diabetes patients, female with non child-bearing potential. Treated with insulin for more than 3 years. Well controlled HbA1c. Have a body mass index (BMI) ≥19 and ≤35 Exclusion Criteria: Clinically significant illness except type I diabetes, or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product Daily use of nicotine containing substances.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klas Malmberg, MD, PhD, Prof
Organizational Affiliation
AstraZeneca R&D Mölndal
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Emanuel P DeNoia, MD
Organizational Affiliation
Healthcare Discoveries LLC Icon Development Solutions
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research site
City
San Antonio
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

To Evaluate the Bioavailability of a Tablet of AZD1656

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