HealthyPhase 1NCT00709553
Drug Interaction Study to Asses Multiple Doses of ZD4054 (Zibotentan)
A Phase 1 study testing midazolam and ZD4054 in people with Healthy, run by AstraZeneca at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- midazolam and ZD4054
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2008to Aug 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midazolamDrug
Also called Dormicum®
ZD4054Drug
Also called Zibotentan
ZD4054 10 mg od
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | midazolam, one single dose of 705mg Receives: Drug: midazolam |
| 2 | Experimental | ZD4054(Zibotentan)- 10mg od, 7 days + midazolam (one single dose of 7.5 mg on day 6 ) Receives: Drug: midazolam; Drug: ZD4054 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK variables
Measured: Frequent sampling occasions during study
Secondary outcomes (1)
Safety variables (adverse events, ECG, blood pressure, pulse, safety lab)
Measured: During the whole treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Morris, Study director, AstraZeneca, Medical Science DirectorDago Mazur, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709553
- Sponsor's protocol ID
- D4320C00010
- Other IDs
- ZD4054EudraCt 2008-002764-35
- Status last verified
- Sep 2010
- First submitted
- 1 Jul 2008
- Last updated
- 28 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20678684
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00709553
- Acronym / sponsor ID
- D4320C00010
- Conditions
- Healthy
- Keywords
- ZD4054, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 3 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: midazolammidazolam, one single dose of 705mg |
| 2 | Experimental | Drug: midazolam, Drug: ZD4054ZD4054(Zibotentan)- 10mg od, 7 days + midazolam (one single dose of 7.5 mg on day 6 ) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| midazolamAlso: Dormicum® | Drug | 1, 2 |
| ZD4054Also: ZibotentanZD4054 10 mg od | Drug | 2 |
Primary outcome
PK variables
Time frame: Frequent sampling occasions during study
1 secondary outcome
Safety variables (adverse events, ECG, blood pressure, pulse, safety lab)
Time frame: During the whole treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2010.
- Derived from this study: PubMed 20678684Tomkinson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Morris study director
AstraZeneca, Medical Science Director
Dago Mazur principal investigator
Parexel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing midazolam and ZD4054 in people with Healthy, run by AstraZeneca at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK variables (time frame: Frequent sampling occasions during study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00709553, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2010.