Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Navigate: Correlations HPO
There is one clinical trial.
This is a Phase 1b, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and pharmacokinetic profiles of voriconazole inhalation powder in adult subjects with well-controlled asthma. This study will involve 2 cohorts.
Description: Frequency of AEs, SAEs, and discontinuations due to AEs
Measure: Number of participants who experience Adverse Events (AEs), Serious Adverse Events (SAEs) and withdrawals due to AEs Time: Through study completion, an average of 14 daysDescription: Number of participants with potentially clinically significant vital sign values
Measure: Number of participants who experience vital sign abnormalities Time: Baseline through study completion, an average of 14 daysDescription: Number of participants with potentially clinically significant pulse oximetry values
Measure: Number of participants who experience pulse oximetry abnormalities Time: Baseline through study completion, an average of 14 daysDescription: Spirometry used to measure FEV1 lung function
Measure: Mean change from baseline in forced expiratory volume (FEV1) Time: Baseline through study completion, an average of 14 daysDescription: Spirometry used to measure FVC lung function
Measure: Mean change from baseline in forced vital capacity (FVC) Time: Baseline through study completion, an average of 14 daysDescription: Spirometry used to measure FVC and FEF25-75% lung function
Measure: Mean change from baseline in forced expiratory flow over the middle 1/2 of the FVC (FEF25-75%) Time: Baseline through study completion, an average of 14 daysDescription: Spirometry used to measure FEV1 and FVC lung function
Measure: Mean change from baseline in FEV1/FVC ratio Time: Baseline through study completion, an average of 14 daysDescription: Number of participants with potentially clinically significant ECG values
Measure: Mean change from baseline in QTcF changes via ECG Time: Baseline through study completion, an average of 14 daysDescription: Number of participants with potentially clinically significant physical examination findings
Measure: Number of participants who experience physical examination abnormalities Time: Baseline through study completion, an average of 14 daysDescription: Number of participants with potentially clinically significant laboratory test results
Measure: Number of participants who experience laboratory test abnormalities Time: Baseline through study completion, an average of 14 daysDescription: Blood samples will be collected for plasma analysis
Measure: PK of VIP in plasma: Area under the plasma-concentration time curve (AUC) Time: Predose Day 1 and through 12 hours post last dose (day 4)Description: Blood samples will be collected for analysis
Measure: PK of VIP in plasma: Area under the plasma-concentration time curve over the first 12 hours after dosing (AUC0-12) Time: Predose Day 1 and through 12 hours post last dose (day 4)Description: Blood samples will be collected for analysis
Measure: PK of VIP in plasma: Area under the concentration time curve, from time 0 to the last observed non-zero concentration (AUC0-tlast) Time: Predose Day 1 and through 12 hours post last dose (day 4)Description: Blood samples will be collected for analysis
Measure: PK of VIP in plasma: Area under the concentration time curve from time 0 extrapolated to infinity (AUC∞) Time: Predose Day 1 and through 12 hours post last dose (day 4)Description: Blood samples will be collected for analysis
Measure: PK of VIP in plasma: Maximum observed concentration (Cmax) Time: Predose Day 1 and through 12 hours post last dose (day 4)Description: Blood samples will be collected for analysis
Measure: PK of VIP in plasma: Time to maximal observed concentration (tmax) Time: Predose Day 1 and through 12 hours post last dose (day 4)Description: Blood samples will be collected for analysis
Measure: PK of VIP in plasma: Termination elimination half-life (t½) Time: Predose Day 1 and through 12 hours post last dose (day 4)Description: Blood samples will be collected for analysis
Measure: PK of VIP in plasma: Apparent total body clearance (CL/F) Time: Predose Day 1 and through 12 hours post last dose (day 4)Description: Blood samples will be collected for analysis
Measure: PK of VIP in plasma: Apparent volume of distribution during the terminal elimination phase (Vz/F) Time: Predose Day 1 and through 12 hours post last dose (day 4)Alphabetical 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