Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1616 | GSK3923868 Wiki | 1.00 |
| drug721 | COVI-AMG Wiki | 1.00 |
| drug2296 | Matching placebo Wiki | 0.50 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D001249 | Asthma NIH | 0.28 |
| D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.26 |
| D053120 | Respiratory Aspiration NIH | 0.25 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002099 | Asthma HPO | 0.28 |
| HP:0006510 | Chronic pulmonary obstruction HPO | 0.26 |
Navigate: Correlations HPO
There is one clinical trial.
This is a first time in human (FTIH) study designed to evaluate the safety, tolerability and pharmacokinetic (PK) profile of single and repeat doses of GSK3923868 inhalation powder in both healthy participants and asthmatics. This is a 3-part, randomized, double blind, placebo controlled study of GSK3923868, administered as an inhalation powder blend (GSK3923868 capsules for inhalation) via Mono-dose inhaler in healthy participants (Parts A and B) and in participants with asthma (Part C). The duration of study participation for each part A, B and C will be 11, 9 and 8 weeks, respectively.
Description: AEs and SAEs will be collected.
Measure: Part A: Number of participants with adverse events (AEs) and serious adverse events (SAEs) Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: AEs and SAEs will be collected.
Measure: Part B: Number of participants with AEs and SAEs Time: From start of the treatment (Day 0) to Day 18Description: AEs and SAEs will be collected.
Measure: Part C: Number of participants with AEs and SAEs Time: From start of the treatment (Day 0) to Day 8Description: Blood samples will be collected for the assessment of hematology laboratory (lab) parameters.
Measure: Part A: Number of participants with clinically significant changes in hematology lab parameters Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the assessment of clinical chemistry lab parameters.
Measure: Part A: Number of participants with clinically significant changes in clinical chemistry lab parameters Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Urine samples will be collected for the assessment of urinalysis lab parameters.
Measure: Part A: Number of participants with clinically significant changes in urinalysis lab parameters Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the assessment of hematology lab parameters.
Measure: Part B: Number of participants with clinically significant changes in hematology lab parameters Time: From start of the treatment (Day 0) to Day 18Description: Blood samples will be collected for the assessment of clinical chemistry lab parameters.
Measure: Part B: Number of participants with clinically significant changes in clinical chemistry lab parameters Time: From start of the treatment (Day 0) to Day 18Description: Urine samples will be collected for the assessment of urinalysis lab parameters.
Measure: Part B: Number of participants with clinically significant changes in urinalysis lab parameters Time: From start of the treatment (Day 0) to Day 18Description: Blood samples will be collected for the assessment of hematology lab parameters.
Measure: Part C: Number of participants with clinically significant changes in hematology lab parameters Time: From start of the treatment (Day 0) to Day 8Description: Blood samples will be collected for the assessment of clinical chemistry lab parameters.
Measure: Part C: Number of participants with clinically significant changes in clinical chemistry lab parameters Time: From start of the treatment (Day 0) to Day 8Description: Urine samples will be collected for the assessment of urinalysis lab parameters.
Measure: Part C: Number of participants with clinically significant changes in urinalysis lab parameters Time: From start of the treatment (Day 0) to Day 8Description: Vital signs will be measured in a semi-supine position after atleast 10 minutes rest.
Measure: Part A: Number of participants with clinically significant vital signs Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Vital signs will be measured in a semi-supine position after atleast 10 minutes rest.
Measure: Part B: Number of participants with clinically significant vital signs Time: From start of the treatment (Day 0) to Day 18Description: Vital signs will be measured in a semi-supine position after atleast 10 minutes rest.
Measure: Part C: Number of participants with clinically significant vital signs Time: From start of the treatment (Day 0) to Day 8Description: Twelve-lead electrocardiogram will be performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT intervals (QTc). The QT interval will be corrected for heart rate by Fredericia's formula (QTcF).
Measure: Part A: Number of participants with clinically significant abnormalities in 12-Lead electrocardiogram (ECG) findings Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Twelve-lead electrocardiogram will be performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTc.
Measure: Part B: Number of participants with clinically significant abnormalities in 12-Lead ECG findings Time: From start of the treatment (Day 0) to Day 18Description: Twelve-lead electrocardiogram will be performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTc.
Measure: Part C: Number of participants with clinically significant abnormalities in 12-Lead ECG findings Time: From start of the treatment (Day 0) to Day 8Description: Spirometry measurements including forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) will be assessed
Measure: Part A: Number of participants with clinically significant abnormalities in spirometry measurements Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Spirometry measurements including FEV1 and FVC will be assessed.
Measure: Part B: Number of participants with clinically significant abnormalities in spirometry measurements Time: From start of the treatment (Day 0) to Day 18Description: Spirometry measurements including FEV1 and FVC will be assessed.
Measure: Part C: Number of participants with clinically significant abnormalities in spirometry measurements Time: From start of the treatment (Day 0) to Day 8Description: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part A, Cohort 1 and 2: Area under the plasma GSK3923868 concentration versus time curve from time zero to last quantifiable concentration (AUC[0-t]) Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the concentration of GSK3923868.
Measure: Part A, Cohort 1 and 2: Area under the plasma GSK3923868 concentration versus time curve from time zero to infinity (AUC[0-inf]) Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part A, Cohort 1 and 2: Maximum observed GSK3923868 plasma concentration (Cmax) Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part A, Cohort 1 and 2: Time to maximum observed plasma drug concentration (Tmax) Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part B, Cohort 3 and 4: AUC from time 0 (predose) to time tau (AUC [0-tau]) (tau=24hours for once a day dosing regimen) of GSK3923868 on Day 1 and Day 14 Time: Day 1 and 14: Up to 24 hours post doseDescription: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part B, Cohort 3 and 4: Cmax of GSK3923868 on Day 1 and Day 14 Time: Day 1 and Day 14Description: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part B, Cohort 3 and 4: Tmax of GSK3923868 on Day 1 and Day 14 Time: Day 1 and Day 14Description: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part C: AUC (0-tau) (tau=24hours for once a day dosing regimen)of GSK3923868 on Day 1 and Day 7 Time: Day 1 and 7: Up to 24 hours post doseDescription: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part C: Cmax of GSK3923868 on Day 1 and Day 7 Time: Day 1 and Day 7Description: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part C: Tmax of GSK3923868 on Day 1 and Day 7 Time: Day 1 and Day 7Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports