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This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of AZD7624 in healthy subjects and patients with chronic obstructive pulmonary disease.
A Phase I, Randomized, DoubleBlind Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Inhaled Doses (MAD) of AZD7624 to Healthy Subjects and Patients with COPD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Groups 1-4 multiple ascending doses of AZD7624 Healthy subjects will participate in groups 1-3. In each group 6 subjects will receive AZD7624 and 2 will receive matching placebo. COPD patients will participate in group 4. In this group, 8 patients will receive AZD7624 and 2 patients will receive matching placebo. |
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| 2 | Placebo Comparator | Groups 1-4 multiple ascending doses of placebo Healthy subjects will participate in groups 1-3. In each group 6 subjects will receive AZD7624 and 2 will receive matching placebo. COPD patients will participate in group 4. In this group, 8 patients will receive AZD7624 and 2 will receive matching placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD7624 | Drug | Multiple ascending doses (starting from 300 µg lung deposited dose up to 1200 µg) inhaled IMP via a nebulizer |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Summary of number of subjects who had at least one adverse event in any category (Safety analysis set) | Up to 24 days |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Pharmacokinetic Parameters (AUC(0-tau) ) | Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9. *AUC(0-tau) = AUC(0-last) where for cohorts 2,3,4,5 and 6 tau=24 hours and for cohort 1, tau=12 hours . Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device). Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saeed Khan, MBBS, MRCP | Quintiles Drg Research Centre At Guys Hosipital, 6 Newcomen Street London SE1 1YR | Principal Investigator |
| Naimish Patel, MD | AstraZeneca, Wilmington, US | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
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The screening period for all the subjects was from Day -42 to Day -2. Admission on day -1. A 8 to 9 days treatment period, 7 to 9 days follow up period. It was planned to enrol to 32 healthy volunteers and 20 COPD to the study, but 4 COPD patients (Due to stopping cohort 4 prematurly) and one healthy volunteer (in cohort 3) were not enrolled.
Both the lung deposited doses and total delivered doses are reported in clinical study report, and the conversion is: In cohort 1 to 6, the lung deposited doses 151 µg, 303 µg, 595 µg, 1191 µg, 1160 µg and 580 µg are equivalent to the delivered doses 261µg, 522µg, 1027µg, 2053µg, 1932µg and 966µg, respectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD7624 Healthy Volunteers | Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily |
| FG001 | Placebo Healthy Volunteers | Healthy Volunteers with Placebo, once daily or twice daily |
| FG002 | AZD7624 COPD | COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily |
| FG003 | Placebo COPD | COPD Patients with Placebo, once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All subjects who received at least 1 dose of the investigational product, AZD7624 or placebo and for whom any postdose data were available were included in the analysis (safety population).
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD7624 Healthy Volunteers | Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily |
| BG001 | Placebo Healthy Volunteers | Healthy Volunteers with Placebo, once daily or twice daily |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Adverse Events | Summary of number of subjects who had at least one adverse event in any category (Safety analysis set) | Posted | Number | Participants | Up to 24 days |
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Up to 24 days
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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 | AZD7624 Healthy Volunteers | Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough, Bronchospasm, Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naimish Patel | AstraZeneca | +1 781 839 4061 | Naimish.Patel@astrazeneca.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C000628576 | AZD7624 |
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| Placebo to match | Drug | Multiple doses inhaled placebo via a nebulizer |
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| PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3. |
| Summary of Pharmacokinetic Parameters (Cmax) | Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9. Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device). Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken. | PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3. |
| Summary of Pharmacokinetic Parameters (Cmin) | Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9. Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device). Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken. | PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3. |
| BG002 | AZD7624 COPD | COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily |
| BG003 | Placebo COPD | COPD Patients with Placebo, once daily |
| BG004 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| OG003 | Placebo COPD | COPD Patients with Placebo, once daily |
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| Secondary | Summary of Pharmacokinetic Parameters (AUC(0-tau) ) | Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9. *AUC(0-tau) = AUC(0-last) where for cohorts 2,3,4,5 and 6 tau=24 hours and for cohort 1, tau=12 hours . Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device). Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken. | PK analysis set | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3. |
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|
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| Secondary | Summary of Pharmacokinetic Parameters (Cmax) | Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9. Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device). Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken. | PK analysis set | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3. |
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| Secondary | Summary of Pharmacokinetic Parameters (Cmin) | Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9. Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device). Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken. | PK analysis set | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3. |
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| 0 |
| 23 |
| 6 |
| 23 |
| EG001 | Placebo Healthy Volunteers | Healthy Volunteers with Placebo, once daily or twice daily | 0 | 8 | 3 | 8 |
| EG002 | AZD7624 COPD | COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily | 0 | 11 | 7 | 11 |
| EG003 | Placebo COPD | COPD Patients with Placebo, once daily | 0 | 5 | 2 | 5 |
| Mouth ulceration, Dry mouth, Nausea | Gastrointestinal disorders | MedDRA version 15.1 | Systematic Assessment |
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| Chest discomfort, Vessel puncture site bruise | General disorders | MedDRA version 15.1 | Systematic Assessment |
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| Nasopharyngitis, Upper respiratory tract infection, Rhinitis, Tooth abscess | Infections and infestations | MedDRA version 15.1 | Systematic Assessment |
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| Back Pain, Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 15.1 | Systematic Assessment |
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| Dizziness, Headache, Presyncope | Nervous system disorders | MedDRA version 15.1 | Systematic Assessment |
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| Papule, Rash | Skin and subcutaneous tissue disorders | MedDRA version 15.1 | Systematic Assessment |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |