Chronic Obstructive Pulmonary DiseasePhase 1NCT01222442
To Evaluate the Effect of AZD3199 on the Electrical Activity in the Heart
A Phase 1 study testing AZD3199 and Moxifloxacin in people with Chronic Obstructive Pulmonary Disease and Lung Disease, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The purpose of this research study is to evaluate the effect of AZD3199 on the electrical activity of the heart. The effect of AZD3199 will be compared to a licensed antibiotic (moxifloxacin). Moxifloxacin effects on the electrical activity of the heart are well known. 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
- Chronic Obstructive Pulmonary Disease, Lung Disease
- What is being tested?
- AZD3199 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
- Nov 2010to Feb 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 18 to 45 years (inclusive)
- Have a body mass index (BMI) between 19 and 30 kg/m2 and a body weight between 60 and 100 kg.
- Be a non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start.
- Be able to inhale from the Turbuhaler inhaler according to given instructions.
Who cannot join
- Any clinically significant disease or disorder
- Any clinically relevant abnormal findings at screening examination
- History of additional risk factors for Torsade de Pointes (eg, heart failure, hypokalaemia, or family history of long QT syndrome).
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Randomised, Double-blind, Double-dummy, Placebo Controlled, 4-way Crossover Phase I Study to Investigate the Effect of 2 Single Doses (400 μg and 1200 µg) of Inhaled AZD3199 on QT/QTc Interval, Compared to Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers
The purpose of this research study is to evaluate the effect of AZD3199 on the electrical activity of the heart. The effect of AZD3199 will be compared to a licensed antibiotic (moxifloxacin). Moxifloxacin effects on the electrical activity of the heart are well known. Safety and tolerability of AZD3199 and how much AZD3199 enters the blood circulation will also be assessed.
- Being tested
- AZD3199, Moxifloxacin, Placebo comparator
- Keywords
- Respiratory disease, Bronchiolitis, Emphysema, Lung disease causing persistent narrowing of the airways
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Respiration Disorders, Bronchiolitis, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3199Drug
Single dose, oral inhalation
MoxifloxacinDrug
Also called Avelox®
Single dose, oral encapsulated tablet
Placebo comparatorOther
Single dose, oral inhalation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 400 µg AZD3199 + moxifloxacin placebo Receives: Drug: AZD3199 |
| 2 | Experimental | 1200 µg AZD3199 + moxifloxacin placebo Receives: Drug: AZD3199 |
| 3 | Active comparator | AZD3199 placebo + moxifloxacin 400 mg Receives: Drug: Moxifloxacin |
| 4 | Placebo comparator | AZD3199 placebo + moxifloxacin placebo Receives: Other: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the effect of AZD3199 on the QT interval
QTcF or QTcI (algorithm based decision)
Measured: Throughout the study
Secondary outcomes (3)
To investigate the effect of AZD3199 on additional electrocardiogram variables
- QTcF or QTcI dependent on variable confirmed as primary
- Holter-Bin QT
Measured: Throughout the study
To assess the pharmacokinetics of single doses of AZD3199.
- AUC(0-24)
- Cmax
- tmax
Measured: Throughout the study
To evaluate the safety and tolerability of single doses of AZD3199.
- Adverse events - type of events and number of subjects experiencing adverse events.
- Laboratory safety assessments, pulse, blood pressure and electrocardiogram interpretation - Summarised using descriptive stats. Judged regarding high/low values or changes from pre-dose.
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carin Jorup, MD, Study director, AstraZeneca R&D, Lund, SwedenLeonard Siew, MB CHB, Principal investigator, Quintiles Drug Research Unit at Guy's Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222442
- Sponsor's protocol ID
- D0570C00004
- Status last verified
- Feb 2011
- First submitted
- 12 Oct 2010
- Last updated
- 16 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Randomised, Double-blind, Double-dummy, Placebo Controlled, 4-way Crossover Phase I Study to Investigate the Effect of 2 Single Doses (400 μg and 1200 µg) of Inhaled AZD3199 on QT/QTc Interval, Compared to Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01222442
- Acronym / sponsor ID
- D0570C00004
- Keywords
- Respiratory disease, Bronchiolitis, Emphysema, Lung disease causing persistent narrowing of the airways
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 18 Oct 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 AZD3199 on the electrical activity of the heart. The effect of AZD3199 will be compared to a licensed antibiotic (moxifloxacin). Moxifloxacin effects on the electrical activity of the heart are well known. Safety and tolerability of AZD3199 and how much AZD3199 enters the blood circulation will also be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD3199400 µg AZD3199 + moxifloxacin placebo |
| 2 | Experimental | Drug: AZD31991200 µg AZD3199 + moxifloxacin placebo |
| 3 | Active comparator | Drug: MoxifloxacinAZD3199 placebo + moxifloxacin 400 mg |
| 4 | Placebo comparator | Other: Placebo comparatorAZD3199 placebo + moxifloxacin placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects aged 18 to 45 years (inclusive)
- Have a body mass index (BMI) between 19 and 30 kg/m2 and a body weight between 60 and 100 kg.
- Be a non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start.
- Be able to inhale from the Turbuhaler inhaler according to given instructions.
Key exclusion criteria (4 listed)
- Any clinically significant disease or disorder
- Any clinically relevant abnormal findings at screening examination
- History of additional risk factors for Torsade de Pointes (eg, heart failure, hypokalaemia, or family history of long QT syndrome).
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
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 |
|---|---|---|
| AZD3199Single dose, oral inhalation | Drug | 1, 2 |
| MoxifloxacinAlso: Avelox®Single dose, oral encapsulated tablet | Drug | 3 |
| Placebo comparatorSingle dose, oral inhalation | Other | 4 |
Primary outcome
To investigate the effect of AZD3199 on the QT interval
Time frame: Throughout the study
QTcF or QTcI (algorithm based decision)
3 secondary outcomes
To investigate the effect of AZD3199 on additional electrocardiogram variables
Time frame: Throughout the study
To assess the pharmacokinetics of single doses of AZD3199.
Time frame: Throughout the study
To evaluate the safety and tolerability of single doses of AZD3199.
Time frame: Throughout the study
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 Feb 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.
Carin Jorup, MD study director
AstraZeneca R&D, Lund, Sweden
Leonard Siew, MB CHB principal investigator
Quintiles Drug Research Unit at Guy's Hospital, 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 AZD3199 and Moxifloxacin in people with Chronic Obstructive Pulmonary Disease and Lung Disease, 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 4 inclusion and 4 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 Feb 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 investigate the effect of AZD3199 on the QT interval (time frame: Throughout the study). 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 Feb 2011.