Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1608 | GSK3640254 Wiki | 0.50 |
| drug444 | BAY1817080 Wiki | 0.41 |
| drug2916 | Placebo Wiki | 0.06 |
Navigate: Correlations HPO
There are 2 clinical trials
In this study, researchers want to find whether the study drug BAY1817080 has an effect on the electrocardiogram (ECG). 40 healthy male or female participants with the age of 18 to 65 years will be enrolled into this study. The ECG of the participants will be monitored closely by the researchers to detect any change after intake of the study medication.
Description: Area under the concentration vs. time curve from zero to 24 hours after multiple doses
Measure: AUC(0-24)md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose Time: Predose and up to 24 hours after last dose of BAY1817080 at Day 3Description: Area under the concentration vs. time curve from zero to infinity after single dose
Measure: AUC after a single oral dose of moxifloxacin Time: Predose and up to 24 hours after single dose of moxifloxacin at Day 3Description: Maximum observed drug concentration in measured matrix after multiple doses
Measure: Cmax,md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose Time: Up to 24 hours after last dose of BAY1817080 at Day 3Description: Maximum observed drug concentration in measured matrix after single dose
Measure: Cmax after a single oral dose of moxifloxacin Time: Up to 24 hours after single dose of moxifloxacin at Day 3This study will aim to evaluate the effect of therapeutic and supratherapeutic oral doses of GSK3640254 on cardiac conduction compared to placebo and a single oral dose of Moxifloxacin in healthy adult participants. The study has 2 parts: Part 1 will determine the supratherapeutic dose for Part 2, which will be the main corrected QT interval (QTc) study. Part 1 consists of 2 sequential cohorts: Sentinel Cohort 1 will evaluate once daily (QD) dosing of GSK3640254 or placebo for 7 days and Sentinel Cohort 2 will evaluate twice daily (BID) dosing of GSK3640254 or placebo for 7 days. Part 2 will investigate the safety, tolerability and Pharmacokinetics (PK) of GSK3640254 doses on cardiac conduction as compared to placebo and a single oral dose of Moxifloxacin in healthy adult participants. Moxifloxacin will be included as a positive control. All doses of study intervention will be administered under fed conditions and will receive a moderate-fat meal 30 minutes prior to dosing. The total duration of the study is approximately 91 days. Approximately 58 participants will be enrolled in the study.
Description: Blood samples will be collected at the indicated time points for PK analysis of GSK3640254.
Measure: Part 1: Area under the plasma concentration-time curve from time zero to time t (AUC[0-t]) of GSK3640254 Time: Up to Day 9 of each cohortDescription: Blood samples will be collected at the indicated time points for PK analysis of GSK3640254.
Measure: Part 1: AUC from time zero to the end of the dosing interval at steady state (AUC[0-tau]) of GSK3640254 Time: Up to Day 9 of each cohortDescription: Blood samples will be collected at the indicated time points for PK analysis of GSK3640254.
Measure: Part 1: Maximum observed concentration (Cmax) of GSK3640254 Time: Up to Day 9 of each cohortDescription: Blood samples will be collected at the indicated time points for PK analysis of GSK3640254.
Measure: Part 1: Plasma concentration at the end of the dosing interval (Ctau) of GSK3640254 Time: Up to Day 9 of each cohortDescription: Blood samples will be collected at the indicated time points for PK analysis of GSK3640254.
Measure: Part 1: Time of maximum observed concentration (Tmax) of GSK3640254 Time: Up to Day 9 of each cohortDescription: Blood samples will be collected for measurement of plasma concentrations of GSK3640254 and its major metabolite.
Measure: Part 1: Plasma concentrations of GSK3640254 and its major metabolite Time: Up to Day 9 of each cohortDescription: All AEs and SAEs will be assessed.
Measure: Part 1: Number of participants with adverse events (AEs) and serious AEs (SAEs) Time: Up to Day 9 of each cohortDescription: Blood samples will be collected for the assessment of hematology and chemistry parameters.
Measure: Part 1: Number of participants with abnormal laboratory parameters Time: Up to Day 9 of each cohortDescription: Urine samples will be collected for the assessment of urinalysis parameters.
Measure: Part 1: Number of participants with abnormal urinalysis parameters Time: Up to Day 9 of each cohortDescription: Number of participants with abnormal ECG parameters will be assessed.
Measure: Part 1: Number of participants with abnormal electrocardiogram (ECG) parameters Time: Up to Day 9 of each cohortDescription: Number of participants with abnormal vital signs will be assessed.
Measure: Part 1: Number of participants with abnormal vital signs Time: Up to Day 9 of each cohortDescription: Placebo-corrected change from Baseline in QTcF will be analyzed.
Measure: Part 2: Placebo-corrected change from Baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF) following administration of GSK3640254 (Milliseconds [ms]) Time: Baseline (Day -1) and up to Day 51Description: Blood samples will be collected for measurement of plasma concentrations of GSK3640254 and its major metabolite.
Measure: Part 2: Plasma concentrations of GSK3640254 and its major metabolite Time: Up to Day 51Description: Change from Baseline in heart rate will be analyzed.
Measure: Part 2: Change from Baseline in heart rate (HR) (Beats per minute [bpm]) Time: Baseline (Day -1) and up to Day 51Description: Change from Baseline in QTcF, PR interval and QRS interval will be analyzed.
Measure: Part 2: Change from Baseline in QTcF, PR interval and QRS interval (ms) Time: Baseline (Day -1) and up to Day 51Description: Placebo-corrected change from Baseline in HR will be analyzed.
Measure: Part 2: Placebo-corrected change from Baseline in HR (bpm) Time: Baseline (Day -1) and up to Day 51Description: Placebo-corrected change from Baseline in QTcF, PR interval and QRS interval will be analyzed.
Measure: Part 2: Placebo-corrected change from Baseline in QTcF, PR interval and QRS interval (ms) Time: Baseline (Day -1) and up to Day 51Description: Number of participants with abnormal HR, QTcF, PR interval and QRS interval will be assessed.
Measure: Part 2: Number of participants with abnormal HR, QTcF, PR interval and QRS interval Time: Up to Day 51Description: Number of participants with treatment emergent changes of T-wave morphology will be evaluated.
Measure: Part 2: Number of participants with treatment emergent changes of T-wave morphology Time: Up to Day 51Description: Number of participants with presence of U-wave will be evaluated.
Measure: Part 2: Number of participants with presence of U-wave Time: Up to Day 51Description: Placebo-corrected change from Baseline in QTcF will be analyzed.
Measure: Part 2: Placebo-corrected change from Baseline in QTcF following administration of Moxifloxacin (ms) Time: Baseline (Day -1) and up to Day 51Description: Blood samples will be collected at the indicated time points for PK analysis of GSK3640254.
Measure: Part 2: AUC(0-t) of GSK3640254 Time: Up to Day 51Description: Blood samples will be collected at the indicated time points for PK analysis of GSK3640254.
Measure: Part 2: AUC(0-tau) of GSK3640254 Time: Up to Day 51Description: Blood samples will be collected at the indicated time points for PK analysis of GSK3640254.
Measure: Part 2: Cmax of GSK3640254 Time: Up to Day 51Description: Blood samples will be collected at the indicated time points for PK analysis of GSK3640254.
Measure: Part 2: Ctau of GSK3640254 Time: Up to Day 51Description: Blood samples will be collected at the indicated time points for PK analysis of GSK3640254.
Measure: Part 2: Tmax of GSK3640254 Time: Up to Day 51Description: Blood samples will be collected at the indicated time points for PK analysis of Moxifloxacin.
Measure: Part 2: Cmax of Moxifloxacin Time: Up to Day 51Description: Blood samples will be collected at the indicated time points for PK analysis of Moxifloxacin.
Measure: Part 2: Tmax of Moxifloxacin Time: Up to Day 51Description: All AEs and SAEs will be assessed.
Measure: Part 2: Number of participants with AEs and SAEs Time: Up to Day 51Description: Blood samples will be collected for the assessment of hematology and chemistry parameters.
Measure: Part 2: Number of participants with abnormal laboratory parameters Time: Up to Day 51Description: Urine samples will be collected for the assessment of urinalysis parameters.
Measure: Part 2: Number of participants with abnormal urinalysis parameters Time: Up to Day 51Description: Number of participants with abnormal ECG parameters will be assessed.
Measure: Part 2: Number of participants with abnormal ECG parameters Time: Up to Day 51Description: Number of participants with abnormal vital signs will be assessed.
Measure: Part 2: Number of participants with abnormal vital signs Time: Up to Day 51Alphabetical 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