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There is one clinical trial.
This is a clinical pharmacology study to characterize the biotransformation and excretion of [14C]CC-90001 and to evaluate the safety and tolerability of [14C]CC-90001 following a single oral dose of [14C]CC-90001 in healthy male subjects. Approximately 8 subjects will be enrolled into the study with a goal of 6 subjects being eligible for analysis.
Description: Total [14C]-Radioactivity (RA) in whole blood, plasma, urine, and feces) will be measured via Liquid scintillation counting (LSC)
Measure: Pharmacokinetics - Total [14C]-RA Time: Up to approximately 216 hours post doseDescription: The total recovery of radioactivity will be computed as the sum of the cumulative excretion (as % dose) in urine and feces
Measure: Pharmacokinetics - Cumulative excretion of total [14C]-RA Time: Up to approximately 13 daysDescription: Total [14C]-RA in whole blood and plasma will be converted to ngEq/mL concentration of [14C]CC-90001 based on specific activity of the dose. Equivalent concentration-time profiles will be determined.
Measure: Pharmacokinetics - Total [14C]-RA whole blood-to-plasma ratios Time: Up to approximately 216 hours postDescription: The RA will be determined for CC-90001 and any identified metabolites in plasma. Metabolite profiling may use pooled time points.
Measure: Pharmacokinetics - metabolite profiling in plasma Time: Up to approximately 216 hours postDescription: Percentage of the administered dose, and the RA, will be determined for CC-90001 and any identified metabolites in urine and feces. Metabolite profiling may use pooled collection intervals.
Measure: Pharmacokinetics - metabolite profiling in urine and feces Time: Up to approximately 13 daysDescription: Observed maximum concentration of [14C]CC-90001 and for metabolites with sufficient measurable concentration
Measure: Pharmacokinetics - Cmax Time: Up to approximately 216 hours postDescription: Area under the concentration-time curve of [14C]CC-90001 and for metabolites with sufficient measureable concentration
Measure: Pharmacokinetics - AUC Time: Up to approximately 216 hours postDescription: Time to Cmax of [14C]CC-90001 and for metabolites with sufficient measureable concentration
Measure: Pharmacokinetics - Tmax Time: Up to approximately 216 hours postDescription: Terminal elimination half-life of [14C]CC-90001 and for metabolites with sufficient measureable concentration
Measure: Pharmacokinetics - t1/2 Time: Up to approximately 216 hours postDescription: An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Measure: Number of treatment-emergent adverse event related to CC-90001 Time: From enrollment until at least 28 days after completion of study treatmentAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 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.
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