An Interaction Study of Ketoconazole/Verapamil Versus AZD1305

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Ketoconazole; Drug: AZD1305; Drug: Verapamil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00707551

2008-000578-18 (EudraCT No)

D3190C00009

Details and patient eligibility

About

The purpose is to study whether ketoconazole or verapamil have an effect on how AZD1305 is handled by the body, i.e the absorption, distribution, metabolism and excretion, when administered in combination with AZD1305.

Enrollment: 27 estimated 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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27 participants in 3 patient groups

1

Experimental group

Description:

Ketoconazole tablet + AZD1305 Extended Release tablet

Treatment:

Drug: AZD1305

Drug: Ketoconazole

2

Experimental group

Description:

Verapamil Extended Release tablet + AZD1305 Extended Release tablet

Treatment:

Drug: Verapamil

Drug: AZD1305

3

Experimental group

Description:

AZD1305 Extended Release tablet

Treatment:

Drug: AZD1305