To Evaluate the Bioavailability of a Tablet of AZD1656

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00817505
First received: December 24, 2008
Last updated: November 2, 2009
Last verified: November 2009
  Purpose

To evaluate the bioavailability of a tablet of AZD1656.


Condition Intervention Phase
Type 1 Diabetes
Drug: AZD1656
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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) [ Time Frame: Blood samples taken up to 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacodynamic variables (Plasma glucose) [ Time Frame: Taken repeatedly during treatment periods ] [ Designated as safety issue: No ]
  • Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables) [ Time Frame: Taken during treatment periods ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: December 2008
Study Completion Date: September 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
AZD1656 tablet + food
Drug: AZD1656
Single dose oral tablet
Drug: AZD1656
Single dose oral suspension
Active Comparator: 2
AZD1656 susp. without food
Drug: AZD1656
Single dose oral tablet
Drug: AZD1656
Single dose oral suspension
Active Comparator: 3
AZD1656 tablet
Drug: AZD1656
Single dose oral tablet
Drug: AZD1656
Single dose oral suspension

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817505

Locations
United States, Texas
Research site
San Antonio, Texas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Klas Malmberg, MD, PhD, Prof AstraZeneca R&D Mölndal
Principal Investigator: Emanuel P DeNoia, MD Healthcare Discoveries LLC Icon Development Solutions
  More Information

No publications provided

Responsible Party: Klas Malmberg, MD, PhD, Prof. Medical Science Director, Emerging Products, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00817505     History of Changes
Other Study ID Numbers: D1020C00010
Study First Received: December 24, 2008
Last Updated: November 2, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Type I diabetes
bioavailability

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014