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OpenTrials
Completed

NCT Number: NCT00817505

To Evaluate the Bioavailability of a Tablet of AZD1656

To evaluate the bioavailability of a tablet of AZD1656.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research site

San Antonio, Texas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD1656

Drug

Single dose oral tablet

Primary outcomes

  1. 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 outcomes

  1. Pharmacodynamic variables (Plasma glucose)

    Time frame: Taken repeatedly during treatment periods

  2. Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables)

    Time frame: Taken during treatment periods

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 6, 2009
Registry last updated
Nov 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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