To Evaluate the Bioavailability of a Tablet of AZD1656

Phase 1

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: AZD1656

• Registration Number: NCT00817505
• Lead Sponsor: AstraZeneca

Brief Summary

To evaluate the bioavailability of a tablet of AZD1656.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-24
• Study First Submitted QC: 2009-01-05
• Study First Posted: 2009-01-06
• Primary Completion: 2009-03
• Study Completion: 2009-09
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-02
• Last Update Posted: 2009-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	AZD1656	AZD1656 susp. without food
3	AZD1656	AZD1656 tablet
1	AZD1656	AZD1656 tablet + food

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic variables (Plasma glucose)	Taken repeatedly during treatment periods
Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables)	Taken during treatment periods

Trial Locations

Locations (1)

Research site; 🇺🇸 San Antonio, Texas, United States