Chronic Obstructive Pulmonary DiseasePhase 1NCT01068184
A Study to Assess Safety, Tolerability and Pharmacokinetics of of AZD6553 in Healthy Volunteers and Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 1 study testing AZD6553 in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
AZD6553 is a new drug being developed as a possible treatment for patients with chronic obstructive pulmonary disease (COPD). COPD refers to chronic bronchitis and emphysema, a pair of two commonly co-existing diseases of the lungs in which the airways become inflamed and the small airsacs of the lungs become damaged. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- AZD6553
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2010to May 2010
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parts A and B only; Body mass index (BMI) between 18 and 30 kg/m2.
- Parts A and B only; Normal physical examination, laboratory values, and vital signs (blood pressure and pulse) unless the investigator considers an abnormality to be clinically irrelevant.
- Part C only; clinical diagnosis of COPD for at least one year and Post-bronchodilator FEV1 30 - 80% predicted, FEV1/FVC ratio < 70%
Who cannot join
- Participation in any clinical study with an investigational drug or new formulation of a marketed drug in the 3 months prior to Visit 2, or participation in a method development study one month prior to Visit 1
- Part C only: An acute exacerbation or acute respiratory infection (upper or lower) in the 4 weeks prior to Visit 1 or Visit 2.
- Part C only: Concomitant diagnosis of significant pulmonary disease other than COPD, including symptomatic asthma, cystic fibrosis and allergic bronchopulmonary aspergillosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomised, Double-Blind, Placebo-Controlled, 3-Part Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of AZD6553 in Healthy Volunteers (Parts A and B) and Patients (Part C) With Chronic Obstructive Pulmonary Disease
AZD6553 is a new drug being developed as a possible treatment for patients with chronic obstructive pulmonary disease (COPD). COPD refers to chronic bronchitis and emphysema, a pair of two commonly co-existing diseases of the lungs in which the airways become inflamed and the small airsacs of the lungs become damaged. This leads to a limitation of the flow of air to and from the lungs causing shortness of breath. In contrast to asthma, the limitation of airflow is poorly reversible and usually gets progressively worse over time. There is an urgent medical need for therapies that could slow disease progression by targeting the underlying mechanisms associated with the changes in the lungs in patients with COPD. AZD6553 acts by reducing the activity of a protease found to be involved in the disease process in COPD. AZD6553 is being developed as a novel oral treatment to control the symptoms and exacerbations of COPD, and reduce the progression and severity of the disease. The purpose of this research study is to determine how safe and well-tolerated AZD6553 is and how much AZD6553 enters blood circulation by collecting blood and urine samples during the study. We are also investigating what AZD6553 is broken down into, when given orally, how much of the drug is cleared from the body via the kidneys, and the effect of taking the drug after food. This will all be done by analysis of blood and urine samples taken at various point during the study.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- AZD6553, Placebo
- Keywords
- AZD6553, Chronic, obstructive, pulmonary, lung, respiratory disease, placebo-controlled, COPD, Healthy Volunteers, COPD Patients
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchiolitis Obliterans Syndrome, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6553Drug
Single or multiple oral dose
PlaceboDrug
single or multiple oral dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD6553 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety variables (adverse events, ECG's blood pressure, pulse, safety lab)
Measured: Part A Intensive sampling for 24 hours , frequent sampling up to 72 hours, Part B Frequent Sampling over 12 days with intensive sampling on Days 1-2 and 8-9
Pharmacokinetic variables:-Cmax, AUC, tmax and t1/2
Measured: Part A Intensive sampling for 24 hours , frequent sampling up to 72 hours, Part B Frequent Sampling over 12 days with intensive sampling on Days 1-2 and 8-9
Secondary outcomes (2)
Lung Function SVC, IC, FEV1, FVC
Measured: Part C Days 2, 7 and 14
Pharmacokinetic variables; Urine CLR
Measured: Part A Days 1 and 2, Part B, Days 1 and 2 and Days 8,9 and 10, and Part C Day 1 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: temporary hold in May 2010 due to an emerging PK profile that could not be aligned to the known pharmaceutical properties of the IMP (AZD6553).
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Investigators
- T G K Mant, FRCP (UK) FFPM, Principal investigator, Quintiles Drug Research Unit at Guy's HospitalJoanna Marks-Konczalik, Study director, AstraZeneca R&D Charnwood
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068184
- Sponsor's protocol ID
- D2580C00001
- Other IDs
- 2009-016931-36, 2009
- Status last verified
- Sep 2010
- First submitted
- 11 Feb 2010
- Last updated
- 24 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Double-Blind, Placebo-Controlled, 3-Part Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of AZD6553 in Healthy Volunteers (Parts A and B) and Patients (Part C) With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01068184
- Acronym / sponsor ID
- D2580C00001
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- AZD6553, Chronic, obstructive, pulmonary, lung, respiratory disease, placebo-controlled, COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: temporary hold in May 2010 due to an emerging PK profile that could not be aligned to the known pharmaceutical properties of the IMP (AZD6553).
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Feb 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 12 Feb 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.
AZD6553 is a new drug being developed as a possible treatment for patients with chronic obstructive pulmonary disease (COPD). COPD refers to chronic bronchitis and emphysema, a pair of two commonly co-existing diseases of the lungs in which the airways become inflamed and the small airsacs of the lungs become damaged. This leads to a limitation of the flow of air to and from the lungs causing shortness of breath. In contrast to asthma, the limitation of airflow is poorly reversible and usually gets progressively worse over time. There is an urgent medical need for therapies that could slow disease progression by targeting the underlying mechanisms associated with the changes in the lungs in patients with COPD. AZD6553 acts by reducing the activity of a protease found to be involved in the disease process in COPD. AZD6553 is being developed as a novel oral treatment to control the symptoms and exacerbations of COPD, and reduce the progression and severity of the disease. The purpose of this research study is to determine how safe and well-tolerated AZD6553 is and how much AZD6553 enters blood circulation by collecting blood and urine samples during the study. We are also investigating what AZD6553 is broken down into, when given orally, how much of the drug is cleared from the body via the kidneys, and the effect of taking the drug after food. This will all be done by analysis of blood and urine samples taken at various point during the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD6553 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parts A and B only; Body mass index (BMI) between 18 and 30 kg/m2.
- Parts A and B only; Normal physical examination, laboratory values, and vital signs (blood pressure and pulse) unless the investigator considers an abnormality to be clinically irrelevant.
- Part C only; clinical diagnosis of COPD for at least one year and Post-bronchodilator FEV1 30 - 80% predicted, FEV1/FVC ratio < 70%
Key exclusion criteria (3 listed)
- Participation in any clinical study with an investigational drug or new formulation of a marketed drug in the 3 months prior to Visit 2, or participation in a method development study one month prior to Visit 1
- Part C only: An acute exacerbation or acute respiratory infection (upper or lower) in the 4 weeks prior to Visit 1 or Visit 2.
- Part C only: Concomitant diagnosis of significant pulmonary disease other than COPD, including symptomatic asthma, cystic fibrosis and allergic bronchopulmonary aspergillosis
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 |
|---|---|---|
| AZD6553Single or multiple oral dose | Drug | 1 |
| Placebosingle or multiple oral dose | Drug | 2 |
Primary outcome
Safety variables (adverse events, ECG's blood pressure, pulse, safety lab)
Time frame: Part A Intensive sampling for 24 hours , frequent sampling up to 72 hours, Part B Frequent Sampling over 12 days with intensive sampling on Days 1-2 and 8-9
Pharmacokinetic variables:-Cmax, AUC, tmax and t1/2
Time frame: Part A Intensive sampling for 24 hours , frequent sampling up to 72 hours, Part B Frequent Sampling over 12 days with intensive sampling on Days 1-2 and 8-9
2 secondary outcomes
Lung Function SVC, IC, FEV1, FVC
Time frame: Part C Days 2, 7 and 14
Pharmacokinetic variables; Urine CLR
Time frame: Part A Days 1 and 2, Part B, Days 1 and 2 and Days 8,9 and 10, and Part C Day 1 and Day 14
Results and safety
The study was stopped early (reason given: temporary hold in May 2010 due to an emerging PK profile that could not be aligned to the known pharmaceutical properties of the IMP (AZD6553).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 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.
T G K Mant, FRCP (UK) FFPM principal investigator
Quintiles Drug Research Unit at Guy's Hospital
Joanna Marks-Konczalik study director
AstraZeneca R&D Charnwood
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 AZD6553 in people with Chronic Obstructive Pulmonary 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 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: stopped early, as of the sponsor's last update on 24 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 was stopped early (reason given: temporary hold in May 2010 due to an emerging PK profile that could not be aligned to the known pharmaceutical properties of the IMP (AZD6553).). Results are not available in the source record.
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?
Safety variables (adverse events, ECG's blood pressure, pulse, safety lab) (time frame: Part A Intensive sampling for 24 hours , frequent sampling up to 72 hours, Part B Frequent Sampling over 12 days with intensive sampling on Days 1-2 and 8-9). The study lists 2 primary outcomes in all. 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 24 Sep 2010.