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An Interaction Study of Ketoconazole/Verapamil Versus AZD1305

NCT ID: NCT00707551

Last Updated: 2010-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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AZD1305 Verapamil Ketoconazole pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Ketoconazole tablet + AZD1305 Extended Release tablet

Group Type EXPERIMENTAL

Ketoconazole

Intervention Type DRUG

Tablet, administered as repeated doses.

AZD1305

Intervention Type DRUG

Extended Release tablet, administered as a single dose.

2

Verapamil Extended Release tablet + AZD1305 Extended Release tablet

Group Type EXPERIMENTAL

Verapamil

Intervention Type DRUG

Extended Release tablet, administered as repeated doses.

AZD1305

Intervention Type DRUG

Extended Release tablet, administered as a single dose.

3

AZD1305 Extended Release tablet

Group Type EXPERIMENTAL

AZD1305

Intervention Type DRUG

Extended Release tablet, administered as a single dose.

Interventions

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Ketoconazole

Tablet, administered as repeated doses.

Intervention Type DRUG

Verapamil

Extended Release tablet, administered as repeated doses.

Intervention Type DRUG

AZD1305

Extended Release tablet, administered as a single dose.

Intervention Type DRUG

Other Intervention Names

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Fungoral Isoptin Retard

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Helen Lunde, MD

Role: STUDY_DIRECTOR

AstraZeneca R&D, Mölndal, Sweden

Dago Mazur, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

PAREXEL International GmbH, Berlin, Germany

Locations

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Research Site

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2008-000578-18 (EudraCT No)

Identifier Type: -

Identifier Source: secondary_id

D3190C00009

Identifier Type: -

Identifier Source: org_study_id