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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014