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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00709553
First received: July 1, 2008
Last updated: September 27, 2010
Last verified: September 2010
History of Changes
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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:

U.S. FDA Resources

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
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

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

No publications provided by AstraZeneca

Additional 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
Study First Received: July 1, 2008
Last Updated: September 27, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
ZD4054
Healthy Volunteers

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

ClinicalTrials.gov processed this record on June 18, 2013