Development of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents
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|ClinicalTrials.gov Identifier: NCT01976078|
Recruitment Status : Completed
First Posted : November 5, 2013
Last Update Posted : February 20, 2018
|Condition or disease||Intervention/treatment|
|Pharmacokinetics Voriconazole||Drug: Midazolam/Ranitidine/Esomeprazole|
|Study Type :||Observational|
|Actual Enrollment :||45 participants|
|Official Title:||Ontogeny of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents|
|Actual Study Start Date :||September 2012|
|Actual Primary Completion Date :||April 22, 2015|
|Actual Study Completion Date :||April 22, 2015|
All enrolled subjects will have a study pharmacokinetic visit where they will be given the above cocktail of drugs along with their clinically indicated voriconazole dose, followed by blood sampling over the next 12 hours.
Each of the three drugs will be given at 10% of their usual doses for age/weight.
- Voriconazole steady-state pharmacokinetics [ Time Frame: During the 12 hours after a dose ]8 (after intravenous dosing) or 9 (after oral dosing) samples are taken after a voriconazole dose over a 12 hour timeframe.
- Voriconazole drug metabolizing enzyme activity [ Time Frame: Within 12 hours after a study medication dosing ]At the time of the voriconazole dose used for the primary outcome, an intravenous or oral cocktail of "probe drugs", depending on the route of the voriconazole dose, consisting of midazolam, ranitidine, and esomeprazole will be administered. Using the samples collected for the primary outcome, concentrations of all three probe drugs and their major metabolites will be measured and used to compute activity of the relevant drug metabolizing enzymes.
- Accuracy of computer software for Bayesian dose optimization of voriconazole in individual patients [ Time Frame: Within 4 weeks of study completion for each subject ]Using existing voriconazole pharmacokinetic data, we have constructed a population model of the drug's behavior in children and adults. We are testing the use of this model in study subjects to compare the doses predicted by the software to achieve actual, measured voriconazole concentrations obtained for routine clinical care after the study PK visit, with the real doses that were administered and resulted in those measured voriconazole concentrations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01976078
|United States, California|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027|
|Principal Investigator:||Michael N Neely, MD||Children's Hospital Los Angeles|