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

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

July 1, 2008
July 3, 2008
September 28, 2010
July 2008
August 2008   (Final data collection date for primary outcome measure)
PK variables [ Time Frame: Frequent sampling occasions during study ]
Same as current
Complete list of historical versions of study NCT00709553 on Archive Site
Safety variables (adverse events, ECG, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment period ]
Same as current
Not Provided
Not Provided
Drug Interaction Study to Asses Multiple Doses of ZD4054 (Zibotentan)
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
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.
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Drug: midazolam
    Other Name: Dormicum®
  • Drug: ZD4054
    ZD4054 10 mg od
    Other Name: Zibotentan
  • Experimental: 1
    midazolam, one single dose of 705mg
    Intervention: Drug: midazolam
  • Experimental: 2
    ZD4054(Zibotentan)- 10mg od, 7 days + midazolam (one single dose of 7.5 mg on day 6 )
    • Drug: midazolam
    • Drug: ZD4054
Tomkinson HK, Kemp JV, Wollseifen T, Morris T, Oliver SD. An open-label, randomized, single-center, two-period, phase I, crossover study of the effect of zibotentan (ZD4054) on the pharmacokinetics of midazolam in healthy male volunteers. Clin Ther. 2010 Jul;32(7):1372-86. doi: 10.1016/j.clinthera.2010.07.013.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2008
August 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
ZD4054EudraCt 2008-002764-35
Not Provided
Not Provided
Thomas Morris, BSc MB BCh MRCP FFPM, Medical Science Director, ZD4054, AstraZeneca R&D Alderley Park
Not Provided
Study Director: Thomas Morris AstraZeneca, Medical Science Director
Principal Investigator: Dago Mazur Parexel
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP