- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00710047
Food Effect Study of a Single Dose of ZD4054 (Zibotentan)
November 10, 2010 updated by: AstraZeneca
A Randomised, Open-label, Single-centre, Crossover Study in Healthy Male Volunteers to Assess the Effect of Food on the Pharmacokinetics of a 10 mg Single Oral Dose of ZD4054 (Zibotentan)
The purpose of the study is to assess the effect of food on the pharmacokinetics of a 10 mg single oral dose of ZD4054 (Zibotentan)
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Harrow, United Kingdom
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- BMI between 18 and 30 kg/m2
- Medical and surgical history and physical examination without any clinically significant findings
- Able to consume standard FDA specified high-fat breakfast.
Exclusion Criteria:
- Definite or suspected personal history or family history of hypersensitivity to drugs that are endothelin antagonists; ie, ambrisentan, artrasentan, sitaxsetan and bosentan
- Medical diagnosis of migraine with an attack during the 12 months prior to Screening
- Use of prescription medication within 2 weeks before dosing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Fasting state
|
one single 10mg dose
Other Names:
|
EXPERIMENTAL: 2
after high-fat breakfast
|
one single 10mg dose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PK variables
Time Frame: frequent sampling occasions during study days
|
frequent sampling occasions during study days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety variables (adverse events, blood pressure, pulse, safety lab)
Time Frame: During the whole treatment period
|
During the whole treatment period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Wessels, Parexel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (ACTUAL)
August 1, 2008
Study Completion (ACTUAL)
August 1, 2008
Study Registration Dates
First Submitted
July 1, 2008
First Submitted That Met QC Criteria
July 2, 2008
First Posted (ESTIMATE)
July 3, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
November 15, 2010
Last Update Submitted That Met QC Criteria
November 10, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- D4320C00028
- ZD4054EudraCt 2008-002744-42
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Volunteers
-
AstraZenecaCompletedHealthy Elderly Volunteers | Healthy Young VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
University Hospital, Clermont-FerrandUnite de Nutrition Humaine UMR 1019- INRAE; Unite MetaGenoPolis INRAE; France...CompletedHealthy Volunteers | Frail VolunteersFrance
-
Newcastle UniversityCompletedGI Glycaemic Index Healthy Volunteers | GL Glycaemic Load Healthy VolunteersUnited Kingdom
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
Galera Therapeutics, Inc.CelerionCompletedHealthy | Healthy VolunteersUnited States
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
PMV Pharmaceuticals, IncRecruitingHealthy VolunteersUnited States
Clinical Trials on ZD4054
-
University of Wisconsin, MadisonAstraZenecaTerminatedProstate CancerUnited States
-
AstraZenecaCompletedProstatic Neoplasms | Metastases, NeoplasmUnited States
-
AstraZenecaCompletedProstate CancerSweden, United States, Australia, France, United Kingdom, Poland, Finland, Netherlands, Norway, Belgium, Canada, Indonesia, Denmark, Switzerland
-
The Christie NHS Foundation TrustAstraZenecaUnknown
-
University College, LondonMedical Research CouncilCompletedChronic Kidney Disease | Scleroderma | Scleroderma Renal CrisisUnited Kingdom
-
AstraZenecaPRA Health SciencesCompletedHepatic ImpairmentCzech Republic
-
AstraZenecaCompleted10mg ZD4054 (Zibotentan) PK Study in Male, Elderly Chinese Patients With Advanced Solid MalignanciesAdvanced Solid MalignanciesChina
-
AstraZenecaCompletedProstate CancerSweden, United States, Brazil, Czech Republic, France, Russian Federation, United Kingdom, Germany, China, Hungary, Poland, Finland, Netherlands, Mexico, Hong Kong, Australia, Belgium, Canada, Denmark, Portugal, South Africa, Korea... and more
-
AstraZenecaTerminatedProstate CancerSweden, United States, Brazil, Czech Republic, France, Italy, Peru, Russian Federation, Spain, Turkey, United Kingdom, Germany, China, Hungary, Latvia, Poland, Romania, Japan, Finland, Norway, Canada, South Africa, Argentina, Australia, Belgiu... and more
-
Aarhus University HospitalRigshospitalet, DenmarkTerminatedProstate Cancer | MetastasisDenmark