Drug Interaction Study to Asses Multiple Doses of ZD4054 - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00709553

Purpose

The purpose of the study is to to assess the effect of multiple oral doses of ZD4054 on the pharmacokinetics of a CYP450 3A Probe (midazolam) in healthy male subjects.

Condition	Intervention	Phase
Healthy	Drug: midazolam Drug: ZD4054	Phase I

Drug Information available for: Midazolam Midazolam hydrochloride Midazolam maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Official Title:	A Randomised, Open-Label, Crossover, Phase I Study to Assess the Effect of Multiple Oral Doses of ZD4054 on the Pharmacokinetics of a CYP450 3A Probe (Midazolam) in Healthy Male Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

PK variables [ Time Frame: Frequent sampling occasions during study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety variables (adverse events, ECG, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	12
Study Start Date:	July 2008
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental midazolam, one single dose of 705mg	Drug: midazolam
2: Experimental ZD4054 (10mg od, 7 days) + midazolam (one single dose of 7.5 mg on day 6 )	Drug: midazolam Drug: ZD4054 ZD4054 10 mg od

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

BMI between 18 and 30 kg/m2
Medical and surgical history and physical examination without any clinically significant findings
Normal resting ECG with QTcB interval <450ms

Exclusion Criteria:

Definite or suspected personal history or family history of hypersensitivity to drugs that are endothelin antagonists; ie, ambrisentan, artrasentan, sitaxsetan and bosentan
Healthy volunteer has a known hypersensitivity to midazolam or any of the excipients of the midazolam tablet
Medical diagnosis of migraine with an attack during the 12 months prior to Screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709553

Locations

Germany
Research Site
Berlin, Germany

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Thomas Morris	AstraZeneca, Medical Science Director
Principal Investigator:	Dago Mazur	PAREXEL International GmbH

More Information

Responsible Party:	AstraZeneca R&D Alderley Park ( Thomas Morris, BSc MB BCh MRCP FFPM, Medical Science Director, ZD4054 )
Study ID Numbers:	D4320C00010, ZD4054EudraCt 2008-002764-35
Study First Received:	July 1, 2008
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00709553
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

ZD4054
Healthy Volunteers

Study placed in the following topic categories:

Healthy
Midazolam

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Anesthetics

Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009