Covid 19 Research using Clinical Trials (Home Page)
AZD8154 Monodose DPI presented in capsulesWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug122 | AZD8154 Placebo Monodose DPI presented in capsules Wiki | 1.00 |
| drug123 | AZD8154 nebuliser Wiki | 1.00 |
| drug1607 | Losartan Wiki | 0.35 |
| drug2122 | Placebo Wiki | 0.05 |
Correlated MeSH Terms (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D055371 | Acute Lung Injury NIH | 0.10 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.09 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.08 |
| D003141 | Communicable Diseases NIH | 0.08 |
| D007239 | Infection NIH | 0.05 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.05 |
| D018352 | Coronavirus Infections NIH | 0.04 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There is one clinical trial.
Clinical Trials
1 A Randomised, 3 Period, Single Dose, Open-label Crossover Study to Evaluate the Systemic Exposure of AZD8154 While Administered Via Inhalation Using a Nebuliser Formulation and a Monodose Dry Powder Inhaler (DPI) Formulation in Healthy Subjects
This study is intended to evaluate the systemic pharmacokinetic (PK) characteristics and the safety of AZD8154 following administration of the Monodose DPI formulation compared with the administration of the nebuliser suspension.
NCT04480879 Asthma Drug: AZD8154 nebuliser Drug: AZD8154 Monodose DPI presented in capsules Drug: AZD8154 Placebo Monodose DPI presented in capsules
Primary Outcomes
Description: To evaluate the PK characteristics of AZD8154 following inhaled single dose administration of a Monodose DPI formulation when compared with inhaled single dose administration of a nebuliser suspension.
Measure: Area under the plasma concentration time curve from zero to infinity (AUCinf) Time: Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 and 72 hours post dose)Description: To evaluate the PK characteristics of AZD8154 following inhaled single dose administration of a Monodose DPI formulation when compared with inhaled single dose administration of a nebuliser suspension.
Measure: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUClast) Time: Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 and 72 hours post dose)Description: To evaluate the PK characteristics of AZD8154 following inhaled single dose administration of a Monodose DPI formulation when compared with inhaled single dose administration of a nebuliser suspension.
Measure: Maximum observed plasma (peak) drug concentration (Cmax) Time: Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 and 72 hours post dose)Description: To evaluate the PK characteristics of AZD8154 following inhaled single dose administration of a Monodose DPI formulation when compared with inhaled single dose administration of a nebuliser suspension.
Measure: Dose normalised AUCinf Time: Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 and 72 hours post dose)Description: To evaluate the PK characteristics of AZD8154 following inhaled single dose administration of a Monodose DPI formulation when compared with inhaled single dose administration of a nebuliser suspension.
Measure: Dose normalised AUClast Time: Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 and 72 hours post dose)Description: To evaluate the PK characteristics of AZD8154 following inhaled single dose administration of a Monodose DPI formulation when compared with inhaled single dose administration of a nebuliser suspension.
Measure: Dose normalised Cmax Time: Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 and 72 hours post dose)Secondary Outcomes
Description: To evaluate further PK parameters of AZD8154 following inhaled single dose administration of a Monodose DPI formulation and an inhaled single dose administration of a nebuliser suspension.
Measure: Time to reach peak or maximum observed concentration or response following drug administration (tmax) Time: Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 12, 18, 24, 36, 48 and 72 hours post dose)Description: To evaluate further PK parameters of AZD8154 following inhaled single dose administration of a Monodose DPI formulation and an inhaled single dose administration of a nebuliser suspension.
Measure: Half life associated with terminal slope of a semi logarithmic concentration time curve (t½λz) Time: Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 12, 18, 24, 36, 48 and 72 hours post dose)Description: To evaluate further PK parameters of AZD8154 following inhaled single dose administration of a Monodose DPI formulation and an inhaled single dose administration of a nebuliser suspension.
Measure: Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRT) Time: Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 12, 18, 24, 36, 48 and 72 hours post dose)Description: To evaluate further PK parameters of AZD8154 following inhaled single dose administration of a Monodose DPI formulation and an inhaled single dose administration of a nebuliser suspension.
Measure: Terminal elimination rate constant (λz) Time: Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 12, 18, 24, 36, 48 and 72 hours post dose)Description: To evaluate further PK parameters of AZD8154 following inhaled single dose administration of a Monodose DPI formulation and an inhaled single dose administration of a nebuliser suspension.
Measure: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) Time: Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 12, 18, 24, 36, 48 and 72 hours post dose)Description: To evaluate further PK parameters of AZD8154 following inhaled single dose administration of a Monodose DPI formulation and an inhaled single dose administration of a nebuliser suspension.
Measure: Volume of distribution following extravascular administration (based on terminal phase) (Vz/F) Time: Study Day 1 to 4 (Pre dose, 10 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 12, 18, 24, 36, 48 and 72 hours post dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with adverse events Time: Day-1, 1 to 4 (Spontaneous plus pre dose, 3, 12, 24, 48 and 72 hrs post dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal blood pressure Time: At screening (Day-28 to-2), Day-1, Day1 to 4 (Predose and 72hrs post dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal pulse rate Time: At screening (Day-28 to-2), Day-1, Day1 to 4 (Predose and 72hrs post dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal tympanic temperature Time: At screening (Day-28 to-2), Day-1, Day 1 to 4 (Predose, 24, 48, and 72 hrs post dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal respiratory rate Time: At screening (Day-28 to-2), Day-1, Day1 to 4 (Predose and 72hrs post dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal ECG Time: At screening (Day-28 to-2), Day-1, Day 1 to 4 (Predose and 72 hrs post dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal physical examination Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visitDescription: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal spirometry Time: At screening(Day-28 to-2), Day-1, Day1 to 4 (Predose and 30min, 90min, 3hrs, 12hrs and 24hrs postdose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal White blood cell (WBC) count Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Red blood cell (RBC) count Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Haemoglobin (Hb) Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Haematocrit (HCT) Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Mean corpuscular volume (MCV) Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Mean corpuscular haemoglobin (MCH) Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Mean corpuscular haemoglobin concentration (MCHC) Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Neutrophils absolute count Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Lymphocytes absolute count Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Monocytes absolute count Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Eosinophils absolute count Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Basophils absolute count Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Platelets Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Reticulocytes absolute count Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Sodium Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Potassium Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Urea Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Creatinine Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Albumin Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Calcium Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Phosphate Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Glucose(fasting) Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal C-reactive protein (CRP) Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Alkaline phosphatase (ALP) Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Alanine aminotransferase (ALT) Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Aspartate aminotransferase (AST) Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Gamma glutamyl transpeptidase (GGT) Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Total Bilirubin (TBL) Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects
Measure: Number of subjects with abnormal Unconjugated bilirubin Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)Description: To assess the safety of single doses of AZD8154 (Monodose DPI formulation and nebuliser suspension) or placebo (Monodose DPI formulation) in healthy subjects. The parameters to be assessed are glucose, protein and blood in urine
Measure: Number of subjects with abnormal Urinalysis Time: At screening (Day-28 to-2), Day-1, Day1 to 4 and follow-up visit (6± 1 days post last dose)