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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00709553
First Posted: July 3, 2008
Last Update Posted: September 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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 Intervention Phase
Healthy Drug: midazolam Drug: ZD4054 Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

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

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
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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
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


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

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 Submitted: July 1, 2008
First Posted: July 3, 2008
Last Update Posted: September 28, 2010
Last Verified: September 2010

Keywords provided by AstraZeneca:
ZD4054
Healthy Volunteers

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