To Evaluate the Bioavailability of a Tablet of AZD1656

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00817505
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arms: 3
• Duration (Months): 9
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

To evaluate the bioavailability of a tablet of AZD1656.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Drug: AZD1656; Drug: AZD1656	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (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
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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) [Blood samples taken up to 72 hours]

Secondary Outcome Measures

1. Pharmacodynamic variables (Plasma glucose) [Taken repeatedly during treatment periods]

2. Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables) [Taken during treatment periods]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00817505
• Other Study ID Numbers: D1020C00010
• First Posted: Jan 6, 2009
• Last Update Posted: Nov 3, 2009
• Last Verified: Nov 1, 2009

• Keywords provided by , ,: Type I diabetes; bioavailability
• Additional relevant MeSH terms: Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Nov 3, 2009