Rheumatoid ArthritisPhase 1NCT00887770
A Study to Investigate the Potential for AZD5672 to Affect the Electrical Conduction Pathways in the Heart
A Phase 1 study testing AZD5672 and Moxifloxacin in people with Rheumatoid Arthritis, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
This study is being performed to investigate the potential for AZD5672 to affect the electrical conduction pathways in the heart. AZD5672 will be compared against a drug (moxifloxacin - a licensed antibiotic) known to have a detectable but safe change on the electrical conduction of the heart. 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
- Rheumatoid Arthritis
- What is being tested?
- AZD5672 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2009to Jul 2009
- 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
- Body Mass Index (BMI) between 18 and 30 kg/m2 and a minimum weight of 50kg.
- Non-smoker
Who cannot join
- Marked QTc prolongation at baseline e.g. repeated demonstration of QTc interval >450ms or marked shortening of QTcF <350ms
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of the QTc Interval changes
- Use of concomitant medications that prolong QT/QTc interval
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Double-blind, Double-dummy, Randomised, Placebo-controlled, Four-period Crossover Study to Assess the Effect of Single Oral Doses of AZD5672 (600 mg and 150 mg) on QT/QTc Interval, Compared to Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers
This study is being performed to investigate the potential for AZD5672 to affect the electrical conduction pathways in the heart. AZD5672 will be compared against a drug (moxifloxacin - a licensed antibiotic) known to have a detectable but safe change on the electrical conduction of the heart.
- Conditions
- Rheumatoid Arthritis
- Being tested
- AZD5672, Moxifloxacin, placebo
- Keywords
- QTcF, Crossover, ICH E14, QT/QTc prolongation, Moxifloxacin, QT/QTc Interval
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5672Drug
12 x 50mg tablet, oral, single dose
MoxifloxacinDrug
Also called Avelox
1 x 400mg capsule, oral, single dose
placeboDrug
12 x matched to AZD5672 50 mg tablet
AZD5672Drug
3 x 50mg tablet, oral. single dose
placeboDrug
9 x matched to AZD5672 50mg tablet
placeboDrug
1 x matched to Moxifloxacin capsule
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 600mg AZD5672 + Moxifloxacin placebo Receives: Drug: AZD5672; Drug: placebo |
| B | Experimental | 100mg AZD5672 + Moxifloxacin placebo Receives: Drug: AZD5672; Drug: placebo |
| C | Active comparator | AZD5672 placebo + Moxifloxacin 400mg Receives: Drug: Moxifloxacin; Drug: placebo |
| D | Placebo comparator | AZD5672 placebo + Moxifloxacin placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate time-matched QTcF intervals of single dose AZD5672 600mg compared to placebo.
Measured: Up to 24 hours postdose
Secondary outcomes (3)
Evaluate time-matched QTcF Intervals of single dose AZD5672 150mg compared to placebo.
Measured: Up to 24 hours postdose
To evaluate the change in time matched ECG parameters (QTcB, QTcX, RR, PR and QRS) of single dose AZD5672 600mg and 150mg compared to placebo
Measured: Up to 24 hours postdose
To further evaluate the safety and tolerability of single dose AZD5672 600mg and 150mg
Measured: Adverse events assessed throughout the whole study. Safety monitoring (BP, safety blood samples and ECG) conducted frequently throughout study and up to 72 hours post dose on treatment visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2009 (estimated)
- Study startApr 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Investigators
- Mark Layton, Study director, AstraZeneca R&D, Alderley Park, UKDarren Wilbraham, Principal investigator, Guys Drug Research Unit, Newcomen St, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887770
- Sponsor's protocol ID
- D1710C00006
- Other IDs
- Eudract No. 2009-009940-22
- Status last verified
- Jul 2009
- First submitted
- 23 Apr 2009
- Last updated
- 16 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Double-blind, Double-dummy, Randomised, Placebo-controlled, Four-period Crossover Study to Assess the Effect of Single Oral Doses of AZD5672 (600 mg and 150 mg) on QT/QTc Interval, Compared to Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00887770
- Acronym / sponsor ID
- D1710C00006
- Conditions
- Rheumatoid Arthritis
- Keywords
- QTcF, Crossover, ICH E14, QT/QTc prolongation, Moxifloxacin, QT/QTc Interval
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Apr 2009
- Study completion
- Jul 2009 (actual)
- First posted
- 24 Apr 2009 (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 is being performed to investigate the potential for AZD5672 to affect the electrical conduction pathways in the heart. AZD5672 will be compared against a drug (moxifloxacin - a licensed antibiotic) known to have a detectable but safe change on the electrical conduction of the heart.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: AZD5672, Drug: placebo600mg AZD5672 + Moxifloxacin placebo |
| B | Experimental | Drug: AZD5672, Drug: placebo100mg AZD5672 + Moxifloxacin placebo |
| C | Active comparator | Drug: Moxifloxacin, Drug: placeboAZD5672 placebo + Moxifloxacin 400mg |
| D | Placebo comparator | Drug: placeboAZD5672 placebo + Moxifloxacin placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body Mass Index (BMI) between 18 and 30 kg/m2 and a minimum weight of 50kg.
- Non-smoker
Key exclusion criteria (3 listed)
- Marked QTc prolongation at baseline e.g. repeated demonstration of QTc interval >450ms or marked shortening of QTcF <350ms
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of the QTc Interval changes
- Use of concomitant medications that prolong QT/QTc interval
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 |
|---|---|---|
| AZD567212 x 50mg tablet, oral, single dose | Drug | A |
| MoxifloxacinAlso: Avelox1 x 400mg capsule, oral, single dose | Drug | C |
| placebo12 x matched to AZD5672 50 mg tablet | Drug | C, D |
| AZD56723 x 50mg tablet, oral. single dose | Drug | B |
| placebo9 x matched to AZD5672 50mg tablet | Drug | B |
| placebo1 x matched to Moxifloxacin capsule | Drug | A, B, D |
Primary outcome
Evaluate time-matched QTcF intervals of single dose AZD5672 600mg compared to placebo.
Time frame: Up to 24 hours postdose
3 secondary outcomes
Evaluate time-matched QTcF Intervals of single dose AZD5672 150mg compared to placebo.
Time frame: Up to 24 hours postdose
To evaluate the change in time matched ECG parameters (QTcB, QTcX, RR, PR and QRS) of single dose AZD5672 600mg and 150mg compared to placebo
Time frame: Up to 24 hours postdose
To further evaluate the safety and tolerability of single dose AZD5672 600mg and 150mg
Time frame: Adverse events assessed throughout the whole study. Safety monitoring (BP, safety blood samples and ECG) conducted frequently throughout study and up to 72 hours post dose on treatment visits.
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 16 Jul 2009.
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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.
Mark Layton study director
AstraZeneca R&D, Alderley Park, UK
Darren Wilbraham principal investigator
Guys Drug Research Unit, Newcomen St, London
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 AZD5672 and Moxifloxacin in people with Rheumatoid Arthritis, 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 2 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 16 Jul 2009. 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?
Evaluate time-matched QTcF intervals of single dose AZD5672 600mg compared to placebo. (time frame: Up to 24 hours postdose). 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 16 Jul 2009.