To Evaluate the Bioavailability of a Tablet of AZD1656

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00817505
• Other study ID #: D1020C00010
• Status: Completed
• Phase: Phase 1
• First received: December 24, 2008
• Last updated: November 2, 2009
• Start date: December 2008
• Est. completion date: September 2009

Study information

• Verified date: November 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the bioavailability of a tablet of AZD1656.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• AZD1656
Single dose oral tablet
• AZD1656
Single dose oral suspension

Locations

Country	Name	City	State
United States	Research site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		Blood samples taken up to 72 hours	No
Secondary	Pharmacodynamic variables (Plasma glucose)		Taken repeatedly during treatment periods	No
Secondary	Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables)		Taken during treatment periods	No