HealthyPhase 1NCT00713336
Four-period Crossover Study to Assess the Effects of Single Oral Doses of ZD4054 (Zibotentan) (10mg and 30mg) on QTc Interval
A Phase 1 study testing ZD4054 and Moxifloxacin in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
This Study compares two ZD4054 (Zibotentan) doses (10mg and 30mg) with a placebo and a positive control to look at ZD4054 (Zibotentan)'s effect on the ECG of Healthy Volunteer Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ZD4054 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2008to Nov 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non Smoker
- Normal resting 12-lead ECG with normal QTc interval (<450 msec)
- Negative screens for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV) at screening
Who cannot join
- Receipt of another new chemical entity in the 4 months before dosing in this study; participation in another study and participation in a non-invasive methodology study in which no drugs were given within 30 days before dosing in this study
- Risk (in the investigator's opinion) of transmitting, through blood or other body fluids, the agents responsible for acquired immune deficiency syndrome (AIDS), hepatitis B or hepatitis C
- Judgement by the investigator, that the healthy volunteer should not participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Double-blind, Double-dummy, Placebo-controlled, Randomised, Four-period Crossover Study to Assess the Effects of Single Oral Doses of ZD4054 (Zibotentan) (10mg and 30mg) on QTc Interval Compared to Placebo, Using AVELOX (Moxifloxacin) as a Positive Control, in Healthy Volunteers Aged 18 to 45 Years.
This Study compares two ZD4054 (Zibotentan) doses (10mg and 30mg) with a placebo and a positive control to look at ZD4054 (Zibotentan)'s effect on the ECG of Healthy Volunteer
- Conditions
- Healthy
- Being tested
- ZD4054, Moxifloxacin, ZD4054 Placebo, Moxifloxacin placebo
- Keywords
- ZD4054, Healthy Volunteers, QT interval
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD4054Drug
Also called Zibotentan
ZD4054 10mg Tablet
MoxifloxacinDrug
Also called AVELOX
400 mg capsule
ZD4054 PlaceboDrug
3 tablets
Moxifloxacin placeboDrug
1 capsule
ZD4054 PlaceboDrug
2 tablets
ZD4054Drug
30mg tablet
ZD4054Drug
10mg tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ZD4054 + Moxifloxacin placebo Receives: Drug: ZD4054; Drug: Moxifloxacin placebo |
| 2 | Active comparator | ZD4054 placebo + Moxifloxacin Receives: Drug: ZD4054; Drug: Moxifloxacin; Drug: ZD4054 Placebo |
| 3 | Experimental | ZD4054 + ZD4054 placebo + Moxifloxacin placebo Receives: Drug: ZD4054; Drug: Moxifloxacin placebo; Drug: ZD4054 Placebo |
| 4 | Placebo comparator | ZD4054 Placebo + Moxifloxacin placebo Receives: Drug: ZD4054; Drug: ZD4054 Placebo; Drug: Moxifloxacin placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess the maximum of the mean changes in time-matched QTcX (study specific correction) intervals after ZD4054 (Zibotentan) administration (10mg and 30mg) compared to placebo
Measured: Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h
Secondary outcomes (3)
assess the maximum of the mean changes in time-matched QT, QTcB (Bazett's correction), QTcF (Fridericia's correction) and QTcI (subject specific correction) intervals after ZD4054 (Zibotentan) administration (10mg and 30mg) compared to placebo
Measured: Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h
assess the maximum of mean changes in time-matched QTcX, QT, QTcB, QTcF and QTcI intervals after moxifloxacin administration compared to placebo.
Measured: Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h
further assess the safety and tolerability of ZD4054 (Zibotentan) by assessment of adverse events (AEs), laboratory variables and vital signs.
Measured: From time of Consent to Last Follow-up Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startJun 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Raj Chetty, MD, Principal investigator, Clinical Pharmacology UnitAlderley ParkAstraZenecaMacclesfieldSK10 4TG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713336
- Sponsor's protocol ID
- D4320C00017
- Other IDs
- ZD4054IL0017
- Status last verified
- Sep 2010
- First submitted
- 9 Jul 2008
- Last updated
- 28 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
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 Phase I, Double-blind, Double-dummy, Placebo-controlled, Randomised, Four-period Crossover Study to Assess the Effects of Single Oral Doses of ZD4054 (Zibotentan) (10mg and 30mg) on QTc Interval Compared to Placebo, Using AVELOX (Moxifloxacin) as a Positive Control, in Healthy Volunteers Aged 18 to 45 Years.
- ClinicalTrials.gov ID
- NCT00713336
- Acronym / sponsor ID
- D4320C00017
- Conditions
- Healthy
- Keywords
- ZD4054, Healthy Volunteers, QT interval
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Study completion
- Nov 2008 (actual)
- First posted
- 11 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.
This Study compares two ZD4054 (Zibotentan) doses (10mg and 30mg) with a placebo and a positive control to look at ZD4054 (Zibotentan)'s effect on the ECG of Healthy Volunteer
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ZD4054, Drug: Moxifloxacin placeboZD4054 + Moxifloxacin placebo |
| 2 | Active comparator | Drug: ZD4054, Drug: Moxifloxacin, Drug: ZD4054 PlaceboZD4054 placebo + Moxifloxacin |
| 3 | Experimental | Drug: ZD4054, Drug: Moxifloxacin placebo, Drug: ZD4054 PlaceboZD4054 + ZD4054 placebo + Moxifloxacin placebo |
| 4 | Placebo comparator | Drug: ZD4054, Drug: ZD4054 Placebo, Drug: Moxifloxacin placeboZD4054 Placebo + Moxifloxacin placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Non Smoker
- Normal resting 12-lead ECG with normal QTc interval (<450 msec)
- Negative screens for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV) at screening
Key exclusion criteria (3 listed)
- Receipt of another new chemical entity in the 4 months before dosing in this study; participation in another study and participation in a non-invasive methodology study in which no drugs were given within 30 days before dosing in this study
- Risk (in the investigator's opinion) of transmitting, through blood or other body fluids, the agents responsible for acquired immune deficiency syndrome (AIDS), hepatitis B or hepatitis C
- Judgement by the investigator, that the healthy volunteer should not participate in the study
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 |
|---|---|---|
| ZD4054Also: ZibotentanZD4054 10mg Tablet | Drug | 1, 2, 3, 4 |
| MoxifloxacinAlso: AVELOX400 mg capsule | Drug | 2 |
| ZD4054 Placebo3 tablets | Drug | 2, 4 |
| Moxifloxacin placebo1 capsule | Drug | 1, 3, 4 |
| ZD4054 Placebo2 tablets | Drug | 3 |
| ZD405430mg tablet | Drug | 1 |
| ZD405410mg tablet | Drug | 3 |
Primary outcome
to assess the maximum of the mean changes in time-matched QTcX (study specific correction) intervals after ZD4054 (Zibotentan) administration (10mg and 30mg) compared to placebo
Time frame: Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h
3 secondary outcomes
assess the maximum of the mean changes in time-matched QT, QTcB (Bazett's correction), QTcF (Fridericia's correction) and QTcI (subject specific correction) intervals after ZD4054 (Zibotentan) administration (10mg and 30mg) compared to placebo
Time frame: Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h
assess the maximum of mean changes in time-matched QTcX, QT, QTcB, QTcF and QTcI intervals after moxifloxacin administration compared to placebo.
Time frame: Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h
further assess the safety and tolerability of ZD4054 (Zibotentan) by assessment of adverse events (AEs), laboratory variables and vital signs.
Time frame: From time of Consent to Last Follow-up Visit
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.
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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.
Raj Chetty, MD principal investigator
Clinical Pharmacology UnitAlderley ParkAstraZenecaMacclesfieldSK10 4TG
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 ZD4054 and Moxifloxacin in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.
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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
to assess the maximum of the mean changes in time-matched QTcX (study specific correction) intervals after ZD4054 (Zibotentan) administration (10mg and 30mg) compared to placebo (time frame: Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.