An Interaction Study of Ketoconazole/Verapamil Versus AZD1305 - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00707551

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: Ketoconazole Drug: Verapamil Drug: AZD1305	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I, Single-centre, Randomised, Open, Three-way Crossover Study to Evaluate the Effect of Ketoconazole and Verapamil, Respectively, on the Pharmacokinetics of AZD1305 After Repeated Oral Adm of Ketoconazole and Verapamil and Single Oral Dosing of AZD1305 to Young Healthy Male Volunteers

Resource links provided by NLM:

Drug Information available for: Verapamil Diltiazem hydrochloride Dexverapamil Diltiazem Ketoconazole Fungarest Diltiazem malate Verapamil hydrochloride

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Pharmacokinetic variables [ Time Frame: During all dosing visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events, vital signs, ECG, laboratory variables and physical examination [ Time Frame: During the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	27
Study Start Date:	July 2008
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Ketoconazole tablet + AZD1305 Extended Release tablet	Drug: Ketoconazole Tablet, administered as repeated doses. Other Name: Fungoral Drug: AZD1305 Extended Release tablet, administered as a single dose.
Experimental: 2 Verapamil Extended Release tablet + AZD1305 Extended Release tablet	Drug: Verapamil Extended Release tablet, administered as repeated doses. Other Name: Isoptin Retard Drug: AZD1305 Extended Release tablet, administered as a single dose.
Experimental: 3 AZD1305 Extended Release tablet	Drug: AZD1305 Extended Release tablet, administered as a single dose.

Eligibility

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707551

Locations

Germany
Research Site
Berlin, Germany

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Helen Lunde, MD	AstraZeneca R&D Mölndal, Sweden
Principal Investigator:	Dago Mazur, MD, PhD	PAREXEL International GmbH, Berlin, Germany

More Information

No publications provided

Responsible Party:	Helen Lunde, MD, Medical Science Director, Emerging Arrhythmia and Lipids, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00707551 History of Changes
Other Study ID Numbers:	D3190C00009, 2008-000578-18 (EudraCT No)
Study First Received:	June 27, 2008
Last Updated:	December 2, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

AZD1305
Verapamil
Ketoconazole
pharmacokinetics

Additional relevant MeSH terms:

Verapamil
Diltiazem
Ketoconazole
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents

Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 09, 2012