Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
This is a Phase 1, open-label, multiple-dose trial conducted at a single center. The treatment period will consist of three 6 g doses (18 g) of ZTI-01 as a 1-hour intravenous (IV) infusion (+10 minute window). A total of 30 enrolled subjects will be randomized to undergo a single standardized bronchoscopy with bronchoalveolar lavage (BAL) at one of five sampling times. A total of 6 subjects will be assigned to each BAL-sampling time. Up to ten additional enrolled subjects will act as alternates to obtain 30 evaluable subjects. An evaluable subject is defined as a subject who receives all doses of ZTI-01, undergoes BAL at the randomized sampling timepoint with BAL return volume adequate for testing, and undergoes at least the one blood sampling timepoint that is concurrent with the assigned BAL sampling timepoint, with blood sampling volume that is adequate for testing. The objectives of the study are to assess safety and pharmacokinetics (PK) for a multiple dose regimen of IV-infused ZTI-01.
Description: Concentrations will be measured by a validated LC-MS/MS bioanalytical assay for the blood samples collected during the study.
Measure: Area under the concentration vs. time curve (AUC0-8 and AUC0-infinity) for ZTI -01 Time: Day 1 to Day 2Description: Concentrations will be measured by a validated LC-MS/MS bioanalytical assay for the blood samples collected during the study
Measure: Clearance (CL) of ZTI-01 Time: Day 1 to Day 2Description: Defined as percent penetration of lung epithelial lining fluid (ELF) and alveolar macrophages (AMs). The ratios of ELF and AM concentrations of fosfomycin to simultaneous plasma concentrations will be calculated for each subject and summarized for each sampling time. The median concentrations of fosfomycin from the BAL sampling times will be used to estimate the AUC0-8 of plasma, ELF, and AM. The ratio of AUC0-8 of ELF-to-plasma and AM-to-plasma will be calculated to determine the percent penetration.
Measure: Intrapulmonary pharmacokinetics of ZTI-01 Time: Day 1 to Day 2Description: Concentrations will be measured by a validated LC-MS/MS bioanalytical assay for the blood samples collected during the study.
Measure: Maximum measured plasma concentration (Cmax) of ZTI-01 Time: Day 1 to Day 2Description: Clinical laboratory evaluations include serum chemistry (albumin, glucose, blood urea nitrogen (BUN), potassium, magnesium, calcium, sodium, total protein, creatinine, triglycerides, total cholesterol, creatine phosphokinase (CPK), phosphorus, alkaline phosphatase (ALP), AST, ALT, total bilirubin, direct bilirubin, and lactate dehydrogenase (LDH)), hematology (CBC with differential (hemoglobin, hematocrit, platelet count, white blood cell (WBC) count, neutrophils, lymphocytes, monocytes, eosinophils, basophils)), coagulation (PT and aPTT), urinalysis (leukocyte esterase, blood, pH, specific gravity, glucose, protein), and plasma urea concentration.
Measure: Number of participants experiencing abnormal clinical laboratory assessments compared to baseline Time: Day 1 to Day 2Description: Physical exams will include assessment of skin, head and neck, lungs, heart, liver, spleen, extremities, lymph nodes, musculoskeletal system/extremities, abdomen, nervous system, weight, height, and body mass index (BMI).
Measure: Number of participants experiencing abnormal physical examination findings compared to baseline Time: Day 1 to Day 2Description: Vital sign measurements will include heart rate, blood pressure, temperature, respiratory rate, and peripheral oxygen saturation.
Measure: Number of participants experiencing abnormal vital sign measurements compared to baseline Time: Day 1 to Day 2Description: QTc, PR, and QRS intervals are expressed in milliseconds (msec).
Measure: Number of participants with prolonged QTc, PR, or QRS interval in electrocardiogram (ECG) readings Time: Day 1 to Day 2Description: Concentrations will be measured by a validated LC-MS/MS bioanalytical assay for the blood samples collected during the study.
Measure: Terminal elimination half-life (t1/2) of ZTI-01 Time: Day 1 to Day 2Description: Concentrations will be measured by a validated LC-MS/MS bioanalytical assay for the blood samples collected during the study.
Measure: Terminal-phase elimination rate constant (lambdaz) of ZTI-01 Time: Day 1 to Day 2Description: Concentrations will be measured by a validated LC-MS/MS bioanalytical assay for the blood samples collected during the study.
Measure: Time to peak concentration (Tmax) of ZTI-01 Time: Day 1 to Day 2Description: Concentrations will be measured by a validated LC-MS/MS bioanalytical assay for the blood samples collected during the study.
Measure: Volume of ZTI-01 distribution (Vd) Time: Day 1 to Day 2Alphabetical 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