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This is an open-label,partially randomized, four-period study in healthy male subjects to assess the bioavailability and pharmacokinetics of a single dose of AZD7594 when administered intravenously, orally and inhaled via two different dry powder inhalers (DPIs) and a pressurized meter-dose inhaler (pMDI)
This study is an open-label, partially randomized, 4-period, 5-treatment study in healthy male subjects, performed at a single study center. All subjects will receive the 4 of the 5 treatments. The IV infusion will be fixed as the first treatment (Period 1), the Monodose inhaler will be fixed as the second treatment (Period 2) and the oral formulation will be fixed as the fourth treatment (Period 4). During Period 3, subjects are split into 2 equal cohorts, multiple-dose DPI and pMDI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence 1 | Experimental | Treatment Period 1:AZD7594 Solution for infusion (150 μg intravenous formulation) Treatment Period 2:AZD7594 Inhalation powder (400 μg) by dry powder inhaler (DPI) Device 1 (monodose inhaler) Treatment Period 3:AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler) Treatment Period 4:AZD7594 Oral suspension (1200 μg oral formulation) |
|
| Treatment sequence 2 | Experimental | Treatment Period 1:AZD7594 Solution for infusion (150 μg intravenous formulation) Treatment Period 2:AZD7594 Inhalation powder (400 μg) by dry powder inhaler (DPI) Device 1 (monodose inhaler) Treatment Period 3:AZD7594 Pressurized inhalation suspension (400 μg) by pressurized metered-dose inhaler (pMDI) Treatment Period 4:AZD7594 Oral suspension (1200 μg oral formulation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD7594 Solution for infusion (150 μg intravenous formulation) | Drug | Solution for infusion 0.01 mg/ml; AZD7594 150 μg IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of AZD7594 Delivered by Monodose Inhaler and Multiple-dose DPI or pMDI in Terms of Pulmonary Bioavailability After Inhalation (Fpulmonary) | For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594 | 0-96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| PK of AZD7594 Following Oral Administration by Assessment of the Absolute Systemic Bioavailability After Oral Administration (Fpo) | For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594 |
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Inclusion Criteria:
Exclusion Criteria:
History of any clinically significant disease or disorder which, in the opinion of the Investigator, 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 (GI), hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Any clinically significant illness, major medical/surgical procedure, or trauma within 4 weeks of the first administration of Investigational medicinal product (IMP).
Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results at screening and check-in, as judged by the investigator.
Any clinically significant abnormal findings in vital signs after a 5 minute rest at screening and check-in, as judged by the investigator, defined as any of the following:
Any clinically significant abnormities in physical examination or lung function, as judged by the investigator.
Any clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening and check-in, as judged by the investigator.
Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc (QT interval corrected) interval changes. This includes subjects with any of the following:
Prolonged QTcF (QT interval corrected for heart rate using Fridericia's formula) > 450 msec or family history of long QT (ECG interval measured from the onset of the QRS complex to the end of the T wave) syndrome.
Known or suspected history of drug abuse, as judged by the investigator
Current smokers or those who have smoked or used nicotine products within the previous 3 months.
History of alcohol abuse or excessive intake of alcohol as judged by the investigator.
Positive screen for drugs of abuse, alcohol, and cotinine at screening or on each admission to the study center.
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 AZD7594 or to excipients.
Excessive intake of caffeine containing drinks e.g., coffee, tea, caffeine containing energy drinks and cola (in total no more than 3 cups per day).
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 vaccines, antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, vitamins and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life. Occasional use of paracetamol/acetaminophen is allowed for minor pains and headaches (no more than 3000 mg/day).
Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
Has participated in a clinical study investigating clinical evaluation methods 1 month (or at least 5 half-lives) prior to the administration of investigational product.
Known Gilbert's syndrome, family history of Gilbert's syndrome or suspicion of Gilbert's syndrome based on liver function tests.
Any contraindication against the use of vagolytic or sympaticomimetic drugs, as judged by the investigator.
Involvement of any AstraZeneca, PAREXEL or study site employee or their close relatives.
Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) antibody.
Judgment by the investigator that the subject 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.
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Goldwater, M.D | Parexel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baltimore | Maryland | United States |
The IV infusion was fixed as the first treatment (Period 1), the monodose inhaler was fixed as the second treatment (Period 2) and the oral formulation was fixed as the fourth treatment (Period 4). During Period 3, subjects were split into 2 equal cohorts, multiple-dose DPI and pMDI.
This study was conducted at PAREXEL International, Early Phase Clinical Unit, Baltimore, United States of America. A total of 30 subjects were enrolled in the study and Twenty-four subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | IV, DPI 1, DPI 2, Oral | IV formulation, monodose inhaler, multiple-dose DPI, oral formulation |
| FG001 | IV, DPI 1, pMDI, Oral | IV formulation, monodose inhaler, pMDI, oral formulation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| AZD7594 Oral suspension (1200 μg oral formulation) | Drug | 0.1 - 10 mg/g oral solution; AZD7594 1200 μg oral |
|
| AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler) | Drug | Inhalation powder, hard capsules 400 μg Monodose inhaler; AZD7594 400 μg by dry powder inhaler (DPI) Device 1 (Monodose inhaler) |
|
| AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler) | Drug | Inhalation powder, multiple-dose dry powder inhaler (DPI) 400 μg; AZD7594 400 μg by DPI Device 2 (multiple-dose DPI) |
|
| AZD7594 Pressurized inhalation suspension (400 μg) by pMDI | Drug | Inhalation suspension 200 μg; AZD7594 400 μg by pressurized metered-dose inhaler (pMDI); 2 puffs x 200 μg = 400 μg |
|
| 0-96 hours |
| Observed Maximum Plasma Concentration (Cmax) | For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594 | 0-96 hours |
| Area Under the Plasma Concentration-curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) | For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594 | 0-96 hours |
| Absolute Systemic Bioavailability After Inhalation (F Inhalation, Total) | For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594 | 0-96 hours |
| Oral Bioavailability After Inhaled Treatment (F Oral) | For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594 | 0-96 hours |
| Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC) | For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594 | 0-96 hours |
| FG002 | pMDI (Additional) | Pressurized metered-dose inhaler (pMDI) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IV, DPI 1, DPI 2, Oral | IV formulation, monodose inhaler, multiple-dose DPI, oral formulation |
| BG001 | IV, DPI 1, pMDI, Oral | IV formulation, monodose inhaler, pMDI, oral formulation |
| BG002 | pMDI (Additional) | Pressurized metered-dose inhaler (pMDI) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex/Gender, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics (PK) of AZD7594 Delivered by Monodose Inhaler and Multiple-dose DPI or pMDI in Terms of Pulmonary Bioavailability After Inhalation (Fpulmonary) | For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594 | The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage | 0-96 hours |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | PK of AZD7594 Following Oral Administration by Assessment of the Absolute Systemic Bioavailability After Oral Administration (Fpo) | For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594 | The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage | 0-96 hours |
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| Secondary | Observed Maximum Plasma Concentration (Cmax) | For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594 | The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol/L | 0-96 hours |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration-curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) | For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594 | The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | (h*pmol/L) | 0-96 hours |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Systemic Bioavailability After Inhalation (F Inhalation, Total) | For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594 | The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage | 0-96 hours |
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| Secondary | Oral Bioavailability After Inhaled Treatment (F Oral) | For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594 | The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage | 0-96 hours |
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| Secondary | Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC) | For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594 | The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | (h*pmol/L) | 0-96 hours |
|
Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IV Formulation | AZD7594 150 μg IV formulation | 0 | 24 | 2 | 24 | ||
| EG001 | DPI Device 1 | AZD7594 400 μg delivered dose monodose inhaler | 0 | 23 | 0 | 23 | ||
| EG002 | DPI Device 2 | AZD7594 400 μg delivered dose multiple-dose DPI | 0 | 9 | 2 | 9 | ||
| EG003 | pMDI | AZD7594 400 μg delivered dose pMDI | 0 | 10 | 1 | 10 | ||
| EG004 | Oral Formulation | AZD7594 1200 μg oral formulation | 0 | 18 | 1 | 18 | ||
| EG005 | pMDI (Additional) | AZD7594 400 μg delivered dose pMDI (separate treatment) | 0 | 6 | 1 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedD RA version 18.1 | Non-systematic Assessment |
| |
| Ocular hyperemia | Eye disorders | MedD RA version 18.1 | Non-systematic Assessment |
| |
| Infusion site pain | General disorders | MedD RA version 18.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedD RA version 18.1 | Non-systematic Assessment |
| |
| Traumatic hematoma | Injury, poisoning and procedural complications | MedD RA version 18.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedD RA version 18.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedD RA version 18.1 | Non-systematic Assessment |
|
If a publication (e.g., in a scientific journal) based on the results of this study is envisaged, approval from AstraZeneca will be obtained and a draft manuscript will be submitted to AstraZeneca for scrutiny and comment. The choice of conduit will be mutually agreed on by the Principal Investigator and AstraZeneca.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Leader | AstraZeneca AB | +46 31 7761000 | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Not provided
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
Not provided
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| Participants |
|
|
| OG003 |
| 400 µg pMDI (Additional) |
AZD7594 400 μg delivered dose pMDI (Separate treatment) |
| OG004 | 150 µg IV Formulation | AZD7594 150 µg IV formulation |
| OG005 | 1200 µg Oral Formulation | AZD7594 1200 μg oral formulation |
|
|
|
| OG003 | 400 µg pMDI (Additional) | AZD7594 400 μg delivered dose pMDI (Separate treatment) |
| OG004 | 150 µg IV Formulation | AZD7594 150 µg IV formulation |
| OG005 | 1200 µg Oral Formulation | AZD7594 1200 μg oral formulation |
|
|
|
| OG003 | 400 µg pMDI (Additional) | AZD7594 400 μg delivered dose pMDI (Separate treatment) |
|
|
| OG003 |
| 400 µg pMDI (Additional) |
AZD7594 400 μg delivered dose pMDI (Separate treatment) |
|
|
| OG003 | 400 µg pMDI (Additional) | AZD7594 400 μg delivered dose pMDI (Separate treatment) |
| OG004 | 150 µg IV Formulation | AZD7594 150 µg IV formulation |
| OG005 | 1200 µg Oral Formulation | AZD7594 1200 μg oral formulation |
|
|