Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care (PTN_POPS)
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|ClinicalTrials.gov Identifier: NCT01431326|
Recruitment Status : Recruiting
First Posted : September 9, 2011
Last Update Posted : March 22, 2017
|Condition or disease||Intervention/treatment|
|Adenovirus Adrenal Insufficiency Airway Swelling Anesthesia Anxiety Anxiolysis Autism Autistic Disorder Bacterial Meningitis Bacterial Septicemia Benzodiazepine Bipolar Disorder Bone and Joint Infections Brain Swelling Central Nervous System Infections Convulsions Cytomegalovirus Retinitis Early-onset Schizophrenia Spectrum Disorders Edema Epilepsy General Anesthesia Gynecologic Infections Headaches Herpes Simplex Virus Hypertension Infantile Hemangioma Infection Inflammation Inflammatory Conditions Influenza Intra-abdominal Infections Lower Respiratory Tract Infections Migraines Pain Pneumonia Prophylaxis Schizophrenia Sedation Seizures Skeletal Muscle Spasms Skin and Skin-structure Infections Stable Angina Thromboprophylaxis Thrombosis Treatment-resistant Schizophrenia Urinary Tract Infection Withdrawal||Drug: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:|
The purpose of this study is to characterize the PK ( Pharmacokinetics) of understudied drugs administered to children per standard of care as prescribed by their treating caregiver. This will be accomplished by the collection of biological samples during the time of drug administration per standard of care as prescribed by the caregiver. The prescribing of drugs to children will not be part of this protocol.
Aim #1: Evaluate the PK of understudied drugs currently being administered to children.
Hypothesis #1: The PK of understudied drugs in children will differ from adults and within children according to pediatric age groups or special population.
Aim #2: Explore the pharmacodynamics (PD) of understudied drugs currently being administered to children.
Hypothesis #2: The PD of targeted drugs in children will differ from adults.
Aim #3: Evaluate the influence of genetic factors, metabolic and protein profiles on therapeutic exposure.
Hypothesis #3: Genetic polymorphisms in drug metabolizing enzymes and metabolic and proteomic profiles will impact drug exposure in children.
|Study Type :||Observational|
|Estimated Enrollment :||10000 participants|
|Official Title:||Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||February 2018|
Drug: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
- valproic acid
- heparin (low molecular weight)
- warfarin (oral)
- Composite of pharmacokinetic outcomes for understudied drugs in children [ Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days ]
As appropriate for each study drug, the following additional PK parameters will be estimated:
- maximum concentration (Cmax)
- time to achieve maximum concentration (Tmax)
- absorption rate constant (ka)
- elimination rate constant (kel)
- half-life (t1/2)
- area under the curve (AUC)
Penetration into body fluids will be determined by comparing exposure (i.e. AUC, Cmax) ratios between the body fluid and plasma or comparison of concentrations in paired samples.
- Composite pharmacodynamic outcomes of understudied drugs in children [ Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days ]When applicable, Monte Carlo simulations will be performed to evaluate therapeutic target attainment rates (pharmacodynamics) in the population of interest. The final PK model and parameters estimated in the population PK analysis will be used to perform these simulations.
- Biomarkers associated with understudied drugs in children [ Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days ]The dosing, sampling, and demographic information recorded on the eCRF will be merged with the bioanalytical information to create a biomarker dataset for each study drug. Biomarkers will be identified using metabolomics/proteomics and pharmacogenomics methodologies. Samples for biomarker analysis will be stored for future use in a PTN designated biorepository. Associations between biomarkers and drug exposure will be explored by visual inspection (i.e. scatter plots) and statistical comparisons as needed.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431326
|Contact: Chiara Melloni, MDemail@example.com|
|Contact: Barrie L Harper, MT (ASCP)||firstname.lastname@example.org|
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|Principal Investigator:||Michael Cohen-Wolkowiez, MD||Duke University|
|Study Chair:||Chiara Melloni, MD||Duke University|