AsthmaPhase 1NCT01265641
To Investigate the Effects of AZD1981 on the QT Interval
A Phase 1 study testing AZD1981, 2000mg, AZD1981, 200mg and Moxifloxacin, 400mg in people with Asthma, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The purpose of this research study is to evaluate the effect of AZD1981 on the electrical activity of the heart, in particular when the heart muscle is relaxed during a heart beat cycle. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- AZD1981, 2000mg, AZD1981, 200mg and Moxifloxacin, 400mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2011to Apr 2011
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers aged 18 to 55 years (inclusive)
- Subjects must be willing to use barrier methods of contraception during study and for 3 months after last dosing.
- Be a non-smoker or ex-smoker who has stopped smoking for >6 months
Who cannot join
- Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment)
- History of additional risk factors for Torsade de Pointes (eg, heart failure, hypokalemia, personal or family history of arrhythmia or long QT syndrome)
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 in Healthy Male Volunteers, to Assess the Effect on QT/QTc Interval of Single Oral Doses of AZD1981 (200 mg and 2000 mg) Using Moxifloxacin (Avelox®) as a Positive Control
The purpose of this research study is to evaluate the effect of AZD1981 on the electrical activity of the heart, in particular when the heart muscle is relaxed during a heart beat cycle. The effect of AZD1981 will be compared to a licensed antibiotic (moxifloxacin) which is well known to affect the electrical activity of the heart, but this effect is known to be at levels that are safe at the dose used in this study. The investigators will also compare the effects of AZD1981 with a "dummy drug" (placebo). The investigators will also be evaluating how safe and well tolerated AZD1981 is and how much AZD1981 enters the blood circulation by collecting blood during the study.
- Conditions
- Asthma
- Being tested
- AZD1981, 2000mg, AZD1981, 200mg, Moxifloxacin, 400mg, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1981, 2000mgDrug
Single oral dose, tablets
AZD1981, 200mgDrug
Single oral dose, tablets
Moxifloxacin, 400mgDrug
Single oral dose, capsule
PlaceboDrug
Single oral dose, tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD1981, 2000mg |
| 2 | Experimental | Not described Receives: Drug: AZD1981, 200mg |
| 3 | Experimental | Not described Receives: Drug: Moxifloxacin, 400mg |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of a single supra maximal therapeutic dose of AZD1981on QT interval - QTcF
Measured: dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose
Secondary outcomes (3)
To evaluate the effect of a therapeutic dose of AZD1981on QT interval -QTcF
Measured: dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose
To evaluate the effect of AZD1981 on additional electrocardiogram variables - QTcB -RR PR QRS.
Measured: dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose
To evaluate the safety and tolerability of single doses of AZD1981 -frequency of adverse events - laboratory safety assessments - vital signs - physical examination - ECG.
Measured: Adverse events recorded at all four residential visits (one week washout between visits) and at follow up (7-10 days following last residential visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265641
- Sponsor's protocol ID
- D9830C00011
- Other IDs
- 2010-023338-22
- Status last verified
- Jun 2011
- First submitted
- 17 Dec 2010
- Last updated
- 28 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. 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 in Healthy Male Volunteers, to Assess the Effect on QT/QTc Interval of Single Oral Doses of AZD1981 (200 mg and 2000 mg) Using Moxifloxacin (Avelox®) as a Positive Control
- ClinicalTrials.gov ID
- NCT01265641
- Acronym / sponsor ID
- D9830C00011
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 23 Dec 2010 (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 this research study is to evaluate the effect of AZD1981 on the electrical activity of the heart, in particular when the heart muscle is relaxed during a heart beat cycle. The effect of AZD1981 will be compared to a licensed antibiotic (moxifloxacin) which is well known to affect the electrical activity of the heart, but this effect is known to be at levels that are safe at the dose used in this study. The investigators will also compare the effects of AZD1981 with a "dummy drug" (placebo). The investigators will also be evaluating how safe and well tolerated AZD1981 is and how much AZD1981 enters the blood circulation by collecting blood during the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD1981, 2000mg |
| 2 | Experimental | Drug: AZD1981, 200mg |
| 3 | Experimental | Drug: Moxifloxacin, 400mg |
| 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male volunteers aged 18 to 55 years (inclusive)
- Subjects must be willing to use barrier methods of contraception during study and for 3 months after last dosing.
- Be a non-smoker or ex-smoker who has stopped smoking for >6 months
Key exclusion criteria (2 listed)
- Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment)
- History of additional risk factors for Torsade de Pointes (eg, heart failure, hypokalemia, personal or family history of arrhythmia or long QT syndrome)
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 |
|---|---|---|
| AZD1981, 2000mgSingle oral dose, tablets | Drug | 1 |
| AZD1981, 200mgSingle oral dose, tablets | Drug | 2 |
| Moxifloxacin, 400mgSingle oral dose, capsule | Drug | 3 |
| PlaceboSingle oral dose, tablets | Drug | 4 |
Primary outcome
To evaluate the effect of a single supra maximal therapeutic dose of AZD1981on QT interval - QTcF
Time frame: dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose
3 secondary outcomes
To evaluate the effect of a therapeutic dose of AZD1981on QT interval -QTcF
Time frame: dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose
To evaluate the effect of AZD1981 on additional electrocardiogram variables - QTcB -RR PR QRS.
Time frame: dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose
To evaluate the safety and tolerability of single doses of AZD1981 -frequency of adverse events - laboratory safety assessments - vital signs - physical examination - ECG.
Time frame: Adverse events recorded at all four residential visits (one week washout between visits) and at follow up (7-10 days following last residential 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 Jun 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 AZD1981, 2000mg, AZD1981, 200mg and Moxifloxacin, 400mg in people with Asthma, 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 2 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 Jun 2011. 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 evaluate the effect of a single supra maximal therapeutic dose of AZD1981on QT interval - QTcF (time frame: dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose). 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 Jun 2011.