An Interaction Study of Ketoconazole/Verapamil Versus AZD1305

AstraZeneca27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

KetoconazoleDRUG

Tablet, administered as repeated doses.

VerapamilDRUG

Extended Release tablet, administered as repeated doses.

AZD1305DRUG

Extended Release tablet, administered as a single dose.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Berlin, Germany

Outcomes

Primary Outcomes

Pharmacokinetic variables

Time frame: During all dosing visits

Secondary Outcomes

Adverse events, vital signs, ECG, laboratory variables and physical examination

Time frame: During the study

Data from ClinicalTrials.gov

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