An Interaction Study With Digoxin and AZD1305

Atrial Fibrillation Clinical Trial

Official title:

A Phase I, Randomised, Open, Single-centre, Three-period Crossover Study to Evaluate the Effect of AZD1305 on the Pharmacokinetics of Digoxin After Repeated Oral Administration of AZD1305 and Digoxin to Young Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00712465
• Other study ID #: D3190C00010
• Secondary ID: 2008-000577-37 (
• Status: Completed
• Phase: Phase 1
• First received: July 8, 2008
• Last updated: December 2, 2010
• Start date: August 2008
• Est. completion date: November 2008

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to learn more about how digoxin is handled by the body, i.e. absorption, distribution, metabolism and excretion, when administered alone and in combination with AZD1305. Secondary purposes are to learn more about how AZD1305 is handled by the body when administered alone and in combination with digoxin and to learn more about how AZD1305 and digoxin administered alone and in combination affect the body.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• A body mass index (BMI=weight/height2) of 19 to 30 kg/m2

Exclusion Criteria:

• Potassium outside normal reference values

• ECG findings outside normal range

Study Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• AZD1305
Extended Release tablet, repeated administration
• Digoxin
Tablet, repeated administration

Locations

Country	Name	City	State
Sweden	Research Site	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic variables		During all dosing visits	No
Secondary	Adverse event, vital signs, ECG, physical examination and laboratory variables.		During the study	Yes