Asthma, Chronic Obstructive Pulmonary Disease (COPD)Phase 1NCT02928354
A Study to Assess the Effect of Particle Size of AZD7594 on Pharmacokinetics (PK) After a Single Inhaled Dose When Administered Using the Dry Powder Inhaler in Healthy Volunteers
A Phase 1 study testing Treatment A - AZD7594, Treatment B - AZD7594 and Treatment C - AZD7594 in people with Asthma, Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 1 site in Germany.
Trial summary
This study is an open label, randomized, three-way crossover study to assess the effect of particle size on the PK and safety of single inhaled doses of AZD7594 in healthy subjects (males aged 18 to 55 years [inclusive]). The study will be performed at a single study center. 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, Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Treatment A - AZD7594, Treatment B - AZD7594 and Treatment C - AZD7594
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 25 Nov 2016to 21 Mar 2017
- 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
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
- Have a body mass index (BMI) between 18 and 29.9 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
- Subjects should be willing to follow reproductive restrictions to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the first day of dosing until 3 months after the last dose of IMP.
- Be able to inhale from the DPI devices according to given instructions.
- Subjects must read, speak and understand German language.
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the PI, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
- Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis results, at screening and first admission to the study unit as judged by the PI.
- Any clinically significant abnormal findings in vital signs at screening and first admission to the study unit, as judged by the PI. Abnormal vital signs, after 10 minutes supine rest, defined as any of the following: - Systolic BP (SBP) < 90 mmHg or > 140 mmHg - Diastolic BP (DBP) < 50 mmHg or > 90 mmHg - Heart rate < 45 or > 90 beats per minute.
- Any clinically significant abnormalities on 12-lead ECG at screening and first admission to the study unit, as judged by the PI.
Show all 22Show fewer
- Any positive result on screening for serum hepatitis surface antigen or antiHBc antibody suggestive of hepatitis B infection, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
- Known or suspected history of drug abuse, as judged by the PI.
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study. The period of exclusion begins 3 months after the final dose or one month after the last visit whichever is the longest. Note: subjects consented and screened, but not randomized in this study or a previous phase I study, are not excluded.
- Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to AZD7594.
- Current smokers or those who have smoked or used nicotine products within the 3 months prior to screening.
- Subjects who are not able to perform correct spirometry tests at screening.
- Subjects with forced expiratory volume at one second (FEV1) and forced vital capacity (FVC) <80% predicted (calculated) values and FEV1/FVC ratio <0.7 in pulmonary function test (spirometry) at Screening Visit.
- Positive screen for drugs of abuse or cotinine at screening or on each admission to the study center or positive screen for alcohol on each admission to the study center.
- Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.
- Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life.
- Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the PI.
- Involvement of any AstraZeneca, PAREXEL or study site employee or their close relatives.
- Subjects who have previously received AZD7594.
- Judgment by the PI that the volunteer should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
- Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Open Label Three-Way Crossover Study in Healthy Male Volunteers to Investigate the Effect of Particle Size on Pharmacokinetics Following a Single Inhaled Dose of AZD7594 Via a Dry Powder Inhaler
This study is an open label, randomized, three-way crossover study to assess the effect of particle size on the PK and safety of single inhaled doses of AZD7594 in healthy subjects (males aged 18 to 55 years [inclusive]). The study will be performed at a single study center.
Read the detailed description
The study will comprise:
- A Screening period of maximum 28 days.
- Three treatment periods during which subjects will be resident prior to the evening meal the 1 day before dosing with AZD7594 (Day -1) until at least 48 hours after dosing; discharged on the morning of Day 3. Subjects will then return for ambulatory visits 72, 96, 144 and 240 hours after dosing, (Day 4, Day 5, Day 7 and Day 11 respectively).
- A final Follow-up Visit within 10 days after the last administration of AZD7594. This visit will coincide with the last PK sample collection on Day 11 after the last Treatment Period.
There will be a minimum wash-out period of 21 and maximum of 28 days between each dose administration.
Subjects will attend a Screening Visit within 28 days before receiving their first dose of AZD7594, if they are found to be eligible, they return for Treatment Period 1, when they will have baseline assessments, and then will be randomized into one of the 6 treatments sequences. For each Treatment Period, the subjects will receive their investigational medicinal product (IMP) dose in the morning of Day 1, will have further assessments for 48 hours after dosing (residential period) and will return to the study center for ambulatory visits 72, 96, 144 and 240 hours after dosing, (Day 4, Day 5, Day 7 and Day 11 respectively).
Each subject will receive AZD7594 as a single inhaled dose of 440 µg (nominal dose) of each of the following treatments, administered via Dry powder inhaler (DPI):
- Treatment A: Particle size Large
- Treatment B: Particle size Medium
- Treatment C: Particle size Small Each subject will be involved in the study for up to 12 weeks (up to 4 weeks for enrollment and 8 weeks of active study and Follow-up).
- Being tested
- Treatment A - AZD7594, Treatment B - AZD7594, Treatment C - AZD7594
- Keywords
- Asthma, Chronic obstructive pulmonary disease (COPD), Healthy volunteers, Pharmacokinetics (PK), Bioavailability, AZD7594, Safety, Tolerability
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A - AZD7594Drug
Particle size Large as a single inhaled dose of 440 µg (nominal dose), administered via DPI
Treatment B - AZD7594Drug
Particle size Medium as a single inhaled dose of 440 µg (nominal dose), administered via DPI
Treatment C - AZD7594Drug
Particle size Small as a single inhaled dose of 440 µg (nominal dose), administered via DPI
| Study group | Role | What they receive |
|---|---|---|
| Treatment A - AZD7594 | Experimental | Treatment A - AZD7594 inhalation powder Particle size Large Receives: Drug: Treatment A - AZD7594 |
| Treatment B - AZD7594 | Experimental | Treatment B - AZD7594 inhalation powder Particle size Medium Receives: Drug: Treatment B - AZD7594 |
| Treatment C - AZD7594 | Experimental | Treatment C - AZD7594 inhalation powder Particle size Small Receives: Drug: Treatment C - AZD7594 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration-time curve from time zero to infinity (AUC)
Assessment of AUC in healthy male volunteers after the administration of single inhaled dose of AZD7594.
Measured: Pre-dose and at 15, 30, and 45 minutes, and 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48, 72, 96, 144 and 240 hours post dose
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC last)
Assessment of AUC last in healthy male volunteers after the administration of single inhaled dose of AZD7594.
Measured: Pre-dose and at 15, 30, and 45 minutes, and 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48, 72, 96, 144 and 240 hours post dose
Maximum observed plasma concentration (Cmax)
Assessment of Cmax in healthy male volunteers after the administration of single inhaled dose of AZD7594.
Measured: Pre-dose and at 15, 30, and 45 minutes, and 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48, 72, 96, 144 and 240 hours post dose
Secondary outcomes (12)
Time to reach maximum observed plasma concentration (tmax)
Assessment of tmax in healthy male volunteers after the administration of single inhaled dose of AZD7594.
Measured: Pre-dose and at 15, 30, and 45 minutes, and 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48, 72, 96, 144 and 240 hours post dose
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t ½,λz)
Assessment of t ½,λz in healthy male volunteers after the administration of single inhaled dose of AZD7594.
Measured: Pre-dose and at 15, 30, and 45 minutes, and 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48, 72, 96, 144 and 240 hours post dose
Mean residence time from zero to infinity (MRT)
Assessment of MRT in healthy male volunteers after the administration of single inhaled dose of AZD7594.
Measured: pre-dose and at 15, 30, and 45 minutes, and 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48, 72, 96, 144 and 240 hours post dose
Terminal elimination rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve (λz)
Assessment of λz in healthy male volunteers after the administration of single inhaled dose of AZD7594.
Measured: Pre-dose and at 15, 30, and 45 minutes, and 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48, 72, 96, 144 and 240 hours post dose
Apparent total body clearance of drug from plasma after extravascular administration, estimated as dose divided by AUC (CL/F)
Assessment of CL/F in healthy male volunteers after the administration of single inhaled dose of AZD7594.
Measured: pre-dose and at 15, 30, and 45 minutes, and 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48, 72, 96, 144 and 240 hours post dose
Apparent volume of distribution during the terminal phase after extravascular administration estimated by dividing CL/F by λz (Vz/F)
Assessment of (Vz/F) in healthy male volunteers after the administration of single inhaled dose of AZD7594.
Measured: pre-dose and at 15, 30, and 45 minutes, and 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48, 72, 96, 144 and 240 hours post dose
Adverse events (AEs)
Assessment of the safety in terms of the incidences of the AEs after the administration of single inhaled dose of AZD7594.
Measured: Throughout the study ie. from screening (Day -28) upto follow up visit i.e.. 10 days after last IMP administration
Physical examination
Assessment of the safety in terms of the physical examination after the administration of single inhaled dose of AZD7594.
Measured: On screening (Day -28), Day 1 to 3 and follow up visit i.e., 10 days after last IMP administration
Electrocardiogram (ECG)
Assessment of the safety in terms of the ECG after the administration of single inhaled dose of AZD7594.
Measured: Safety ECG will be performed prior to IMP administration and 1, 4 and 24 hours post-IMP administration on Day 1 of each Treatment Period
Vital signs (systolic and diastolic blood pressure [BP], pulse rate)
Assessment of the safety in terms of the Vital signs (systolic and diastolic blood pressure, pulse rate) after the administration of single inhaled dose of AZD7594.
Measured: Vital signs: pulse, blood pressure and oral body temperature will be measured, pre-dose and 1, 4, 24 hours post dose of each Treatment Period
Spirometry
Assessment of the safety in terms of the spirometry after the administration of single inhaled dose of AZD7594.
Measured: On Day 1 of each Treatment Period spirometry will be performed pre-dose and at 0.5 and 1 hours post dose
Clinical laboratory assessments (hematology, clinical chemistry (including serum potassium and glucose)
Assessment of the safety in terms of the Clinical laboratory assessments (hematology, clinical chemistry (including serum potassium and glucose) after the administration of single inhaled dose of AZD7594.
Measured: Safety laboratory tests will be performed at screening, Day 1, Day 11, 240 h post dose and follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study start25 Nov 2016
- Primary completion21 Mar 2017
- Study completion21 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Thomas Körnicke, Principal investigator, PAREXEL Early Phase Clinical Unit Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928354
- Sponsor's protocol ID
- D3741C00006
- Status last verified
- Feb 2018
- First submitted
- 7 Oct 2016
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open Label Three-Way Crossover Study in Healthy Male Volunteers to Investigate the Effect of Particle Size on Pharmacokinetics Following a Single Inhaled Dose of AZD7594 Via a Dry Powder Inhaler
- ClinicalTrials.gov ID
- NCT02928354
- Acronym / sponsor ID
- D3741C00006
- Keywords
- Asthma, Chronic obstructive pulmonary disease (COPD), Healthy volunteers, Pharmacokinetics (PK), Bioavailability, AZD7594, Safety, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2016 (actual)
- Primary completion
- 21 Mar 2017 (actual)
- Study completion
- 21 Mar 2017 (actual)
- First posted
- 10 Oct 2016 (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 is an open label, randomized, three-way crossover study to assess the effect of particle size on the PK and safety of single inhaled doses of AZD7594 in healthy subjects (males aged 18 to 55 years [inclusive]). The study will be performed at a single study center.
Detailed description
The study will comprise:
- A Screening period of maximum 28 days.
- Three treatment periods during which subjects will be resident prior to the evening meal the 1 day before dosing with AZD7594 (Day -1) until at least 48 hours after dosing; discharged on the morning of Day 3. Subjects will then return for ambulatory visits 72, 96, 144 and 240 hours after dosing, (Day 4, Day 5, Day 7 and Day 11 respectively).
- A final Follow-up Visit within 10 days after the last administration of AZD7594. This visit will coincide with the last PK sample collection on Day 11 after the last Treatment Period.
There will be a minimum wash-out period of 21 and maximum of 28 days between each dose administration.
Subjects will attend a Screening Visit within 28 days before receiving their first dose of AZD7594, if they are found to be eligible, they return for Treatment Period 1, when they will have baseline assessments, and then will be randomized into one of the 6 treatments sequences. For each Treatment Period, the subjects will receive their investigational medicinal product (IMP) dose in the morning of Day 1, will have further assessments for 48 hours after dosing (residential period) and will return to the study center for ambulatory visits 72, 96, 144 and 240 hours after dosing, (Day 4, Day 5, Day 7 and Day 11 respectively).
Each subject will receive AZD7594 as a single inhaled dose of 440 µg (nominal dose) of each of the following treatments, administered via Dry powder inhaler (DPI):
- Treatment A: Particle size Large
- Treatment B: Particle size Medium
- Treatment C: Particle size Small Each subject will be involved in the study for up to 12 weeks (up to 4 weeks for enrollment and 8 weeks of active study and Follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A - AZD7594 | Experimental | Drug: Treatment A - AZD7594Treatment A - AZD7594 inhalation powder Particle size Large |
| Treatment B - AZD7594 | Experimental | Drug: Treatment B - AZD7594Treatment B - AZD7594 inhalation powder Particle size Medium |
| Treatment C - AZD7594 | Experimental | Drug: Treatment C - AZD7594Treatment C - AZD7594 inhalation powder Particle size Small |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
- Have a body mass index (BMI) between 18 and 29.9 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
- Subjects should be willing to follow reproductive restrictions to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the first day of dosing until 3 months after the last dose of IMP.
- Be able to inhale from the DPI devices according to given instructions.
Key exclusion criteria (22 listed)
- History of any clinically significant disease or disorder which, in the opinion of the PI, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
- Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis results, at screening and first admission to the study unit as judged by the PI.
- Any clinically significant abnormal findings in vital signs at screening and first admission to the study unit, as judged by the PI. Abnormal vital signs, after 10 minutes supine rest, defined as any of the following: - Systolic BP (SBP) < 90 mmHg or > 140 mmHg - Diastolic BP (DBP) < 50 mmHg or > 90 mmHg - Heart rate < 45 or > 90 beats per minute.
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 |
|---|---|---|
| Treatment A - AZD7594Particle size Large as a single inhaled dose of 440 µg (nominal dose), administered via DPI | Drug | Treatment A - AZD7594 |
| Treatment B - AZD7594Particle size Medium as a single inhaled dose of 440 µg (nominal dose), administered via DPI | Drug | Treatment B - AZD7594 |
| Treatment C - AZD7594Particle size Small as a single inhaled dose of 440 µg (nominal dose), administered via DPI | Drug | Treatment C - AZD7594 |
Primary outcome
Area under plasma concentration-time curve from time zero to infinity (AUC)
Time frame: Pre-dose and at 15, 30, and 45 minutes, and 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48, 72, 96, 144 and 240 hours post dose
Assessment of AUC in healthy male volunteers after the administration of single inhaled dose of AZD7594.
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC last)
Time frame: Pre-dose and at 15, 30, and 45 minutes, and 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48, 72, 96, 144 and 240 hours post dose
Assessment of AUC last in healthy male volunteers after the administration of single inhaled dose of AZD7594.
Maximum observed plasma concentration (Cmax)
Time frame: Pre-dose and at 15, 30, and 45 minutes, and 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48, 72, 96, 144 and 240 hours post dose
Assessment of Cmax in healthy male volunteers after the administration of single inhaled dose of AZD7594.
12 secondary outcomes
Time to reach maximum observed plasma concentration (tmax)
Time frame: Pre-dose and at 15, 30, and 45 minutes, and 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48, 72, 96, 144 and 240 hours post dose
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t ½,λz)
Time frame: Pre-dose and at 15, 30, and 45 minutes, and 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48, 72, 96, 144 and 240 hours post dose
Mean residence time from zero to infinity (MRT)
Time frame: pre-dose and at 15, 30, and 45 minutes, and 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48, 72, 96, 144 and 240 hours post dose
Terminal elimination rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve (λz)
Time frame: Pre-dose and at 15, 30, and 45 minutes, and 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48, 72, 96, 144 and 240 hours post dose
Apparent total body clearance of drug from plasma after extravascular administration, estimated as dose divided by AUC (CL/F)
Time frame: pre-dose and at 15, 30, and 45 minutes, and 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48, 72, 96, 144 and 240 hours post dose
Apparent volume of distribution during the terminal phase after extravascular administration estimated by dividing CL/F by λz (Vz/F)
Time frame: pre-dose and at 15, 30, and 45 minutes, and 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48, 72, 96, 144 and 240 hours post dose
Adverse events (AEs)
Time frame: Throughout the study ie. from screening (Day -28) upto follow up visit i.e.. 10 days after last IMP administration
Physical examination
Time frame: On screening (Day -28), Day 1 to 3 and follow up visit i.e., 10 days after last IMP administration
Electrocardiogram (ECG)
Time frame: Safety ECG will be performed prior to IMP administration and 1, 4 and 24 hours post-IMP administration on Day 1 of each Treatment Period
Vital signs (systolic and diastolic blood pressure [BP], pulse rate)
Time frame: Vital signs: pulse, blood pressure and oral body temperature will be measured, pre-dose and 1, 4, 24 hours post dose of each Treatment Period
Spirometry
Time frame: On Day 1 of each Treatment Period spirometry will be performed pre-dose and at 0.5 and 1 hours post dose
Clinical laboratory assessments (hematology, clinical chemistry (including serum potassium and glucose)
Time frame: Safety laboratory tests will be performed at screening, Day 1, Day 11, 240 h post dose and follow up 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 6 Feb 2018.
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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.
Dr. Thomas Körnicke principal investigator
PAREXEL Early Phase Clinical Unit Berlin
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 Treatment A - AZD7594, Treatment B - AZD7594 and Treatment C - AZD7594 in people with Asthma, Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 1 site in Germany.
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 6 inclusion and 22 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 6 Feb 2018. 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 Germany. 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. 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?
Area under plasma concentration-time curve from time zero to infinity (AUC) (time frame: Pre-dose and at 15, 30, and 45 minutes, and 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48, 72, 96, 144 and 240 hours post dose). The study lists 3 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 6 Feb 2018.