Ignite Creation Date:
2024-05-05 @ 11:51 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01431326
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2011-08-17
Brief Title:
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Sponsor:
Daniel Benjamin
Organization:
Duke University
Study Overview
Official Title:
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PTN_POPS
Brief Summary:
Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved A total of approximately 7000 children aged 21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking The prescribing of drugs to children will not be part of this protocol Taking advantage of procedures done as part of routine medical care ie blood draws this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations ie obese
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IND 113645 | OTHER | None | None |
| IND 114369 | OTHER | None | None |
| IND 114531 | OTHER | None | None |
| IND 118358 | OTHER | None | None |
| HHSN20100006 | OTHER_GRANT | None | None |
| HHSN27500020 | OTHER_GRANT | None | None |
| HHSN27500027 | OTHER_GRANT | None | None |
| HHSN27500043 | OTHER_GRANT | None | None |
| HHSN27500049 | OTHER_GRANT | NICHD | None |