COPDPhase 1NCT01584739
AZD8683 Multiple Dose Study in Healthy Volunteers and Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 1 study testing AZD8683 in people with COPD, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending inhaled doses of AZD8683 in Healthy volunteers and repeated inhalation of one dose level of AZD8683 in patients with chronic obstructive pulmonary disease given once daily. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- AZD8683
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2012to Nov 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male volunteers and healthy female volunteers of non-child bearing potential, aged 18 to 45 years inclusive with suitable veins for cannulation or repeated venepuncture - Healthy volunteers
- Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg inclusive - Healthy volunteers and COPD patients
- Be able to inhale from the Turbuhaler® inhaler according to given instructions as well as be able to perform spirometry -Healthy volunteers and COPD patients.
- Male COPD patients or female COPD patients of non-childbearing potential (post menopausal or surgically sterilised) aged ≥40 years at Visit 1 - COPD patients
- Female healthy volunteers and female patients ≤60 years must have a negative pregnancy test at screening and on admission to the unit - Healthy volunteers and COPD patients
Who cannot join
- Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome - Healthy volunteers and COPD patients
- 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 AZD8683 or excipients:Healthy volunteers and COPD patients
- History or presence of gastrointestinal, pulmonary, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs - Healthy volunteers and COPD patients
- Any clinically significant illness (other than COPD), medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product - COPD patients
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product - Healthy volunteers
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 Multiple Ascending Inhaled Doses of AZD8683 in Healthy Volunteers and COPD Patients
This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending inhaled doses of AZD8683 in Healthy volunteers and repeated inhalation of one dose level of AZD8683 in patients with chronic obstructive pulmonary disease given once daily.
Read the detailed description
A Phase I, Single Centre, Double-Blind, Randomised, Placebo- controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Inhaled Doses of AZD8683 in Healthy Volunteers and COPD patients
- Conditions
- COPD
- Being tested
- AZD8683, Placebo
- Keywords
- Safety, tolerability, healthy, COPD (chronic obstructive pulmonary disease), pharmacokinetic, pharmacodynamic, inhaled
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8683Drug
Multiple dose, oral inhalation (Healthy volunteers) Multiple dose, oral inhalation (COPD patients)
PlaceboDrug
Multiple dose, oral inhalation (Healthy volunteers) Multiple dose, oral inhalation (COPD patients
| Study group | Role | What they receive |
|---|---|---|
| AZD8683 | Experimental | Not described Receives: Drug: AZD8683 |
| Placebo to AZD8683 | 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 profile in terms of: adverse events, Supine vital signs (blood pressure and pulse rate), body temperature, ECG, Physical examinations, Laboratory variables (clinical chemistry, haematology and urinalysis), Spirometry
No formal statistical tests will be performed
Measured: Up to 13 days post dose.
Secondary outcomes (8)
AZD8683 single dose pharmacokinetics from blood and urine in healthy volunteers.
PK parameters:Cmax; tmax -Time to max plasma concentration; t½ λz,AUC-Area under the plasma concentration time curve from zero to infinity;AUC(0-t)-Area under plasma concentration time curve from zero to time of the last measurable concentration; AUC(0-24);AUC(0-72)-Area under the plasma concentration-time curve from zero to 72 hours; CL/F; Vz/F-Apparent volume of distribution during terminal phase; MRT-Mean residence time; Ae; Ae(0-t)-Cumulative amount of AZD8683 excreted unchanged in urine from zero (predose) to time t; fe-Fraction of dose excreted unchanged in urine; CLR-Renal clearance.
Measured: Blood: From days 1 and 15 - Pre-dose, 5, 15 and 30mons, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 hrs (also 96 and 120hrs and follow-up). Urine: From days 1 and 15: pre-dose and 6, 12, 24, 48 and 72hrs.
AZD8683 multiple dose pharmacokinetics from blood and urine in healthy volunteers.
PK paramaters:Cmax and Cmin (max and min plasma concentration);tmax;t½ λz-Terminal half-life; AUC(0-τ)-Area under the plasma concentration-time curve during the dosing interval; Cav-Average plasma concentration;CL/F-Apparent plasma clearance; Rac AUC(0-τ)-Accumulation ratio of AUC(0-τ)compared to AUC(0-24)Day1;Rac Cmax-Accumulation ratio of Cmax compared to Cmax Day 1;Ae(t1-t2), Ae(0-τ)-Amount of drug excreted unchanged in urine in a collection interval; and to the end of the dosing interval respectively;fe(0-τ)-fraction of drug excreted unchanged in urine during a dosing interva;CLR.
Measured: Blood: From days 1 and 15 - Pre-dose, 5, 15 and 30mins, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 hrs (also 96 and 120hrs and follow-up). Urine: From days 1 and 15: pre-dose and 6, 12, 24, 48 and 72hrs.
Description of the pharmacodynamic (PD) effects of AZD8683 in healthy volunteers in terms of : FEV1 and FVC.
Average effect over the first 4 hrs (Eav, AUEC(0-4)/4 hours).Peak effect during the first 4 hrs (Emax).FEV = Forced Expiratory Volume in 1 second. FVC = Forced Vital Capacity.
Measured: Predose, 5mins, 30mins, 1hr, 2hrs, and 4hrs on days 1 and 15.
Description of the pharmacodynamic (PD) effects of AZD8683 in COPD patients in terms of : FEV1 and FVC.
Average effect over the first 4 hrs (Eav, AUEC(0-4)/4 hours).Peak effect during the first 4 hrs (Emax).FEV = Forced Expiratory Volume in 1 second. FVC = Forced Vital Capacity.
Measured: Predose, 5mins, 30mins, 1hr, 2hrs and 4hrs on days 1 and 12.
Description of the pharmacodynamic (PD) effects of AZD8683 in healthy volunteers in terms of : supine blood pressures and pulse rate.
Average effect over the first 4 hrs (Eav, AUEC(0-4)/4 hours).Peak effect during the first 4 hrs (Emax). For diastolic blood pressure the minimum value(Emin), will be used.
Measured: Pre-dose, 30mins, 60mins, 90 mins, 2hrs and 4hrs, on days 1 and 15.
Description of the pharmacodynamic (PD) effects of AZD8683 in COPD patients in terms of : supine blood pressures and pulse rate.
Average effect over the first 4 hrs (Eav, AUEC(0-4)/4 hours).Peak effect during the first 4 hrs (Emax). For diastolic blood pressure the minimum value(Emin), will be used.
Measured: Pre-dose, 30mins, 60mins, 90 mins, 2hrs and 4hrs on days 1 and 12.
Description of the pharmacodynamic (PD) effects of AZD8683 in healthy volunteers in terms of : QT interval corrected for heart rate using Fridericia's formula and heart rate.
Average effect over the first 4 hrs (Eav, AUEC(0-4)/4 hours).Peak effect during the first 4 hrs (Emax).
Measured: 30mins pre-dose and 25 mins, 5mins, 1hr 25 mins, 1hr 55 mins and 3 hr 55 mins, on days 1 and 15.
Description of the pharmacodynamic (PD) effects of AZD8683 in COPD patients in terms of : QT interval corrected for heart rate using Fridericia's formula and heart rate.
Average effect over the first 4 hrs (Eav, AUEC(0-4)/4 hours).Peak effect during the first 4 hrs (Emax).
Measured: 30mins pre-dose and 25 mins, 5mins, 1hr 25 mins, 1hr 55 mins and 3 hr 55 mins on days 1 and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carin Jorup, Study director, AstraZeneca Research and Development SE-431 83 Molndal Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584739
- Sponsor's protocol ID
- D1883C00002
- Other IDs
- Eudract 2011-005588-25
- Status last verified
- Nov 2012
- First submitted
- 2 Apr 2012
- Last updated
- 3 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. 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 Multiple Ascending Inhaled Doses of AZD8683 in Healthy Volunteers and COPD Patients
- ClinicalTrials.gov ID
- NCT01584739
- Acronym / sponsor ID
- D1883C00002
- Conditions
- COPD
- Keywords
- Safety, tolerability, healthy, COPD (chronic obstructive pulmonary disease), pharmacokinetic, pharmacodynamic, inhaled
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 25 Apr 2012 (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 will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending inhaled doses of AZD8683 in Healthy volunteers and repeated inhalation of one dose level of AZD8683 in patients with chronic obstructive pulmonary disease given once daily.
Detailed description
A Phase I, Single Centre, Double-Blind, Randomised, Placebo- controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Inhaled Doses of AZD8683 in Healthy Volunteers and COPD patients
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD8683 | Experimental | Drug: AZD8683 |
| Placebo to AZD8683 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male volunteers and healthy female volunteers of non-child bearing potential, aged 18 to 45 years inclusive with suitable veins for cannulation or repeated venepuncture - Healthy volunteers
- Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg inclusive - Healthy volunteers and COPD patients
- Be able to inhale from the Turbuhaler® inhaler according to given instructions as well as be able to perform spirometry -Healthy volunteers and COPD patients.
- Male COPD patients or female COPD patients of non-childbearing potential (post menopausal or surgically sterilised) aged ≥40 years at Visit 1 - COPD patients
- Female healthy volunteers and female patients ≤60 years must have a negative pregnancy test at screening and on admission to the unit - Healthy volunteers and COPD patients
Key exclusion criteria (5 listed)
- Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome - Healthy volunteers and COPD patients
- 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 AZD8683 or excipients:Healthy volunteers and COPD patients
- History or presence of gastrointestinal, pulmonary, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs - Healthy volunteers and COPD patients
- Any clinically significant illness (other than COPD), medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product - COPD patients
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product - Healthy volunteers
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 |
|---|---|---|
| AZD8683Multiple dose, oral inhalation (Healthy volunteers) Multiple dose, oral inhalation (COPD patients) | Drug | AZD8683 |
| PlaceboMultiple dose, oral inhalation (Healthy volunteers) Multiple dose, oral inhalation (COPD patients | Drug | Placebo to AZD8683 |
Primary outcome
Safety profile in terms of: adverse events, Supine vital signs (blood pressure and pulse rate), body temperature, ECG, Physical examinations, Laboratory variables (clinical chemistry, haematology and urinalysis), Spirometry
Time frame: Up to 13 days post dose.
No formal statistical tests will be performed
8 secondary outcomes
AZD8683 single dose pharmacokinetics from blood and urine in healthy volunteers.
Time frame: Blood: From days 1 and 15 - Pre-dose, 5, 15 and 30mons, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 hrs (also 96 and 120hrs and follow-up). Urine: From days 1 and 15: pre-dose and 6, 12, 24, 48 and 72hrs.
AZD8683 multiple dose pharmacokinetics from blood and urine in healthy volunteers.
Time frame: Blood: From days 1 and 15 - Pre-dose, 5, 15 and 30mins, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 hrs (also 96 and 120hrs and follow-up). Urine: From days 1 and 15: pre-dose and 6, 12, 24, 48 and 72hrs.
Description of the pharmacodynamic (PD) effects of AZD8683 in healthy volunteers in terms of : FEV1 and FVC.
Time frame: Predose, 5mins, 30mins, 1hr, 2hrs, and 4hrs on days 1 and 15.
Description of the pharmacodynamic (PD) effects of AZD8683 in COPD patients in terms of : FEV1 and FVC.
Time frame: Predose, 5mins, 30mins, 1hr, 2hrs and 4hrs on days 1 and 12.
Description of the pharmacodynamic (PD) effects of AZD8683 in healthy volunteers in terms of : supine blood pressures and pulse rate.
Time frame: Pre-dose, 30mins, 60mins, 90 mins, 2hrs and 4hrs, on days 1 and 15.
Description of the pharmacodynamic (PD) effects of AZD8683 in COPD patients in terms of : supine blood pressures and pulse rate.
Time frame: Pre-dose, 30mins, 60mins, 90 mins, 2hrs and 4hrs on days 1 and 12.
Description of the pharmacodynamic (PD) effects of AZD8683 in healthy volunteers in terms of : QT interval corrected for heart rate using Fridericia's formula and heart rate.
Time frame: 30mins pre-dose and 25 mins, 5mins, 1hr 25 mins, 1hr 55 mins and 3 hr 55 mins, on days 1 and 15.
Description of the pharmacodynamic (PD) effects of AZD8683 in COPD patients in terms of : QT interval corrected for heart rate using Fridericia's formula and heart rate.
Time frame: 30mins pre-dose and 25 mins, 5mins, 1hr 25 mins, 1hr 55 mins and 3 hr 55 mins on days 1 and 12.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2012.
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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 study director
AstraZeneca Research and Development SE-431 83 Molndal Sweden
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 AZD8683 in people with COPD, 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 5 inclusion and 5 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 3 Dec 2012. 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. 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 profile in terms of: adverse events, Supine vital signs (blood pressure and pulse rate), body temperature, ECG, Physical examinations, Laboratory variables (clinical chemistry, haematology and urinalysis), Spirometry (time frame: Up to 13 days 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 3 Dec 2012.