Chronic Obstructive Pulmonary DiseasePhase 1NCT01283984
AZD2115 Single Ascending Dose Study
A Phase 1 study testing AZD2115 in people with Chronic Obstructive Pulmonary Disease and Lung Disease Causing Persistent Narrowing of the Airways, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
AZD2115 Single Ascending Dose Study 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 Causing Persistent Narrowing of the Airways
- What is being tested?
- AZD2115
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2011to Aug 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 with suitable veins for cannulation or repeated venepuncture
- Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the day of dosing until 3 months after dosing with the investigational product.
- Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
- Be able to inhale from a Spira nebuliser according to given instructions
Who cannot join
- Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome
- Any clinically important abnormalities in heart rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes. This includes subjects with any of the following:
- PR (PQ) interval prolongation >200 ms (first degree AV block)
- Intermittent second or third degree AV block (based on screening or pre-dose ECG)
- Incomplete, full or intermittent bundle branch block (QRS <110 ms with normal QRS and T wave morphology is acceptable if there is no evidence of left ventricular hypertrophy)
- Abnormal T wave morphology, particularly in the protocol defined primary lead
Show all 10Show fewer
- Dropped beats
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD2115 and/or excipients
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- Serum potassium concentration of <3.80 mmol/L on admission (Day -1)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled AZD2115 After Single Ascending Doses in Healthy Male Subjects
AZD2115 Single Ascending Dose Study
- Conditions
- Chronic Obstructive Pulmonary Disease, Lung Disease Causing Persistent Narrowing of the Airways
- Being tested
- AZD2115, Placebo
- Keywords
- Safety, tolerability, healthy, inhaled, respiratory disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2115Drug
Single dose, oral inhalation (nebuliser solution)
PlaceboDrug
Single dose, oral inhalation (nebuliser solution)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD2115 Receives: Drug: AZD2115 |
| 2 | Placebo comparator | Placebo to AZD2115 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the frequency of adverse events of inhaled single doses of AZD2115
Measured: Measurements will be taken at screening
To evaluate the laboratory safety assessments of inhaled single doses of AZD2115
Measured: Measurements will be taken at screening
To evaluate the vital signs of inhaled single doses of AZD2115
Measured: Measurements will be taken at screening
To evaluate the physical examination of inhaled single doses of AZD2115
Measured: Measurements will be taken at screening
To evaluate the ECG of inhaled single doses of AZD2115
Measured: Measurements will be taken at screening
To evaluate the frequency of adverse events of inhaled single doses of AZD2115
Measured: Measurements will be taken pre-dose
To evaluate the frequency of adverse events of inhaled single doses of AZD2115
Measured: Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose
To evaluate the frequency of adverse events of inhaled single doses of AZD2115
Measured: Measurements will be taken at follow up 7-13 days post dose.
To evaluate the laboratory safety assessments of inhaled single doses of AZD2115
Measured: Measurements will be taken at pre-dose
To evaluate the laboratory safety assessments of inhaled single doses of AZD2115
Measured: Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose
To evaluate the laboratory safety assessments of inhaled single doses of AZD2115
Measured: Measurements will be taken at follow up 7-13 days post dose.
To evaluate the vital signs of inhaled single doses of AZD2115
Measured: Measurements will be taken at pre-dose
To evaluate the vital signs of inhaled single doses of AZD2115
Measured: Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose
To evaluate the vital signs of inhaled single doses of AZD2115
Measured: Measurements will be taken at follow up 7-13 days post dose.
To evaluate the physical examination of inhaled single doses of AZD2115
Measured: Measurements will be taken at pre-dose
To evaluate the physical examination of inhaled single doses of AZD2115
Measured: Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose
To evaluate the physical examination of inhaled single doses of AZD2115
Measured: Measurements will be taken at follow up 7-13 days post dose.
To evaluate the ECG of inhaled single doses of AZD2115
Measured: Measurements will be taken at pre-dose
To evaluate the ECG of inhaled single doses of AZD2115
Measured: Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose
To evaluate the ECG of inhaled single doses of AZD2115
Measured: Measurements will be taken at follow up 7-13 days post dose.
Secondary outcomes (7)
To assess the pharmacokinetics of a single dose of AZD2115 by assessment of area under the curve over the time (AUC) and maximum concentration (Cmax).
Measured: Frequent sampling occasions during study days, before and up to 48 h after dosing
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - FEV1
Measured: Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - potassium
Measured: Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - glucose
Measured: Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - systolic and diastolic blood pressure
Measured: Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - pulse, heart rate
Measured: Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - QTcF
Measured: Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2011
- Study completionAug 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283984
- Sponsor's protocol ID
- D3060C00001
- Status last verified
- Aug 2011
- First submitted
- 5 Jan 2011
- Last updated
- 18 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled AZD2115 After Single Ascending Doses in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01283984
- Acronym / sponsor ID
- D3060C00001
- Conditions
- Chronic Obstructive Pulmonary Disease, Lung Disease Causing Persistent Narrowing of the Airways
- Keywords
- Safety, tolerability, healthy, inhaled, respiratory disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 26 Jan 2011 (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.
AZD2115 Single Ascending Dose Study
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD2115AZD2115 |
| 2 | Placebo comparator | Drug: PlaceboPlacebo to AZD2115 |
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 with suitable veins for cannulation or repeated venepuncture
- Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the day of dosing until 3 months after dosing with the investigational product.
- Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
- Be able to inhale from a Spira nebuliser according to given instructions
Key exclusion criteria (10 listed)
- Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome
- Any clinically important abnormalities in heart rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes. This includes subjects with any of the following:
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD2115 and/or excipients
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- Serum potassium concentration of <3.80 mmol/L on admission (Day -1)
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 |
|---|---|---|
| AZD2115Single dose, oral inhalation (nebuliser solution) | Drug | 1 |
| PlaceboSingle dose, oral inhalation (nebuliser solution) | Drug | 2 |
Primary outcome
To evaluate the frequency of adverse events of inhaled single doses of AZD2115
Time frame: Measurements will be taken at screening
To evaluate the laboratory safety assessments of inhaled single doses of AZD2115
Time frame: Measurements will be taken at screening
To evaluate the vital signs of inhaled single doses of AZD2115
Time frame: Measurements will be taken at screening
To evaluate the physical examination of inhaled single doses of AZD2115
Time frame: Measurements will be taken at screening
To evaluate the ECG of inhaled single doses of AZD2115
Time frame: Measurements will be taken at screening
To evaluate the frequency of adverse events of inhaled single doses of AZD2115
Time frame: Measurements will be taken pre-dose
To evaluate the frequency of adverse events of inhaled single doses of AZD2115
Time frame: Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose
To evaluate the frequency of adverse events of inhaled single doses of AZD2115
Time frame: Measurements will be taken at follow up 7-13 days post dose.
To evaluate the laboratory safety assessments of inhaled single doses of AZD2115
Time frame: Measurements will be taken at pre-dose
To evaluate the laboratory safety assessments of inhaled single doses of AZD2115
Time frame: Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose
To evaluate the laboratory safety assessments of inhaled single doses of AZD2115
Time frame: Measurements will be taken at follow up 7-13 days post dose.
To evaluate the vital signs of inhaled single doses of AZD2115
Time frame: Measurements will be taken at pre-dose
To evaluate the vital signs of inhaled single doses of AZD2115
Time frame: Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose
To evaluate the vital signs of inhaled single doses of AZD2115
Time frame: Measurements will be taken at follow up 7-13 days post dose.
To evaluate the physical examination of inhaled single doses of AZD2115
Time frame: Measurements will be taken at pre-dose
To evaluate the physical examination of inhaled single doses of AZD2115
Time frame: Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose
To evaluate the physical examination of inhaled single doses of AZD2115
Time frame: Measurements will be taken at follow up 7-13 days post dose.
To evaluate the ECG of inhaled single doses of AZD2115
Time frame: Measurements will be taken at pre-dose
To evaluate the ECG of inhaled single doses of AZD2115
Time frame: Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose
To evaluate the ECG of inhaled single doses of AZD2115
Time frame: Measurements will be taken at follow up 7-13 days post dose.
7 secondary outcomes
To assess the pharmacokinetics of a single dose of AZD2115 by assessment of area under the curve over the time (AUC) and maximum concentration (Cmax).
Time frame: Frequent sampling occasions during study days, before and up to 48 h after dosing
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - FEV1
Time frame: Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - potassium
Time frame: Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - glucose
Time frame: Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - systolic and diastolic blood pressure
Time frame: Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - pulse, heart rate
Time frame: Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - QTcF
Time frame: Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.
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 18 Aug 2011.
Related trials for Chronic Obstructive Pulmonary Disease
RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
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 AZD2115 in people with Chronic Obstructive Pulmonary Disease and Lung Disease Causing Persistent Narrowing of the Airways, 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 10 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 18 Aug 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 frequency of adverse events of inhaled single doses of AZD2115 (time frame: Measurements will be taken at screening). The study lists 20 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 18 Aug 2011.