An Interaction Study With Digoxin and AZD1305

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Atrial Fibrillation

Treatments: Drug: Digoxin; Drug: AZD1305

Study type: Interventional

Funder types: Industry

Identifiers

NCT00712465

2008-000577-37 (EudraCT No)

D3190C00010

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

1

Experimental group

Description:

AZD1305 tablet

Treatment:

Drug: AZD1305

2

Experimental group

Description:

AZD1305 tablet + digoxin

Treatment:

Drug: Digoxin

Drug: AZD1305

3

Active Comparator group

Description:

Digoxin

Treatment:

Drug: Digoxin