MedDataX Logo

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

NCT ID: NCT00709553

Last Updated: 2010-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

midazolam, one single dose of 705mg

Group Type EXPERIMENTAL

midazolam

Intervention Type DRUG

2

ZD4054(Zibotentan)- 10mg od, 7 days + midazolam (one single dose of 7.5 mg on day 6 )

Group Type EXPERIMENTAL

midazolam

Intervention Type DRUG

ZD4054

Intervention Type DRUG

ZD4054 10 mg od

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

midazolam

Intervention Type DRUG

ZD4054

ZD4054 10 mg od

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dormicum® Zibotentan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

AstraZeneca R&D Alderley Park

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas Morris

Role: STUDY_DIRECTOR

AstraZeneca, Medical Science Director

Dago Mazur

Role: PRINCIPAL_INVESTIGATOR

Parexel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Berlin, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 20678684 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ZD4054EudraCt 2008-002764-35

Identifier Type: -

Identifier Source: secondary_id

D4320C00010

Identifier Type: -

Identifier Source: org_study_id