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
2 other identifiers
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Jul 2008
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedFirst Posted
Study publicly available on registry
July 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedSeptember 28, 2010
September 1, 2010
1 month
July 1, 2008
September 27, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PK variables
Frequent sampling occasions during study
Secondary Outcomes (1)
Safety variables (adverse events, ECG, blood pressure, pulse, safety lab)
During the whole treatment period
Study Arms (2)
1
EXPERIMENTALmidazolam, one single dose of 705mg
2
EXPERIMENTALZD4054(Zibotentan)- 10mg od, 7 days + midazolam (one single dose of 7.5 mg on day 6 )
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Berlin, Germany
Related Publications (1)
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.
PMID: 20678684DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Thomas Morris
AstraZeneca, Medical Science Director
- PRINCIPAL INVESTIGATOR
Dago Mazur
Parexel
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 1, 2008
First Posted
July 3, 2008
Study Start
July 1, 2008
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
September 28, 2010
Record last verified: 2010-09