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Drug Interaction Study to Asses Multiple Doses of ZD4054 (Zibotentan)

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ClinicalTrials.gov Identifier: NCT00709553
Recruitment Status : Completed
First Posted : July 3, 2008
Last Update Posted : September 28, 2010
Information provided by:

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

Condition or disease Intervention/treatment Phase
Healthy Drug: midazolam Drug: ZD4054 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomised, Open-label, Crossover, Phase I Study to Assess the Effect of Multiple Oral Doses of ZD4054 (Zibotentan) on the Pharmacokinetics of a CYP450 3A Probe (Midazolam) in Healthy Male Subjects
Study Start Date : July 2008
Primary Completion Date : August 2008
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
midazolam, one single dose of 705mg
Drug: midazolam
Other Name: Dormicum®
Experimental: 2
ZD4054(Zibotentan)- 10mg od, 7 days + midazolam (one single dose of 7.5 mg on day 6 )
Drug: midazolam
Other Name: Dormicum®
Drug: ZD4054
ZD4054 10 mg od
Other Name: Zibotentan

Primary Outcome Measures :
  1. PK variables [ Time Frame: Frequent sampling occasions during study ]

Secondary Outcome Measures :
  1. Safety variables (adverse events, ECG, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00709553

Research Site
Berlin, Germany
Sponsors and Collaborators
Study Director: Thomas Morris AstraZeneca, Medical Science Director
Principal Investigator: Dago Mazur Parexel

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Morris, BSc MB BCh MRCP FFPM, Medical Science Director, ZD4054, AstraZeneca R&D Alderley Park
ClinicalTrials.gov Identifier: NCT00709553     History of Changes
Other Study ID Numbers: D4320C00010
ZD4054EudraCt 2008-002764-35
First Posted: July 3, 2008    Key Record Dates
Last Update Posted: September 28, 2010
Last Verified: September 2010

Keywords provided by AstraZeneca:
Healthy Volunteers

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action