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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

July 1, 2008
September 27, 2010
July 2008
August 2008   (final data collection date for primary outcome measure)
PK variables [ Time Frame: Frequent sampling occasions during study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00709553 on ClinicalTrials.gov Archive Site
Safety variables (adverse events, ECG, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment period ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • 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 )
    Interventions:
    • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
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
Male
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00709553
D4320C00010, ZD4054EudraCt 2008-002764-35
No
Thomas Morris, BSc MB BCh MRCP FFPM, Medical Science Director, ZD4054, AstraZeneca R&D Alderley Park
AstraZeneca
Not Provided
Study Director: Thomas Morris AstraZeneca, Medical Science Director
Principal Investigator: Dago Mazur PAREXEL International GmbH
AstraZeneca
September 2010

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