Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

Sponsors

Lead Sponsor: Duke University

Collaborator: The Emmes Company, LLC
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Source Duke University
Brief Summary

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

Overall Status Recruiting
Start Date March 5, 2020
Completion Date April 24, 2024
Primary Completion Date April 24, 2024
Study Type Observational
Primary Outcome
Measure Time Frame
Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Elimination rate constant (ke) as measured by PK sampling Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Half-life (t1/2) as measured by PK sampling Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Absorption rate constant (ka) as measured by PK sampling Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
AUC (area under the curve) as measured by PK sampling Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Maximum concentration (Cmax) as measured by PK sampling Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Time to achieve maximum concentration (Tmax) as measured by PK sampling Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Enrollment 5000
Condition
Intervention

Intervention Type: Drug

Intervention Name: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:

Description: The prescribing of drugs to children is not part of this protocol. Participants will receive DOIs as prescribed by their treating provider.

Arm Group Label: Children and young adults who are prescribed drugs of interest

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

1 (a) Participant is < 21 years of age and is receiving understudied drugs of interest (DOIs) per standard of care (SOC) as prescribed by their treating provider OR (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-CoV-2 positive within 60 days prior to enrollment

2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA

Exclusion Criteria:

1. Participant has a known pregnancy

For participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling:

(Refer to DOI specific appendices for details on enrollment cohort specifications)

2. Has had intermittent dialysis within previous 24 hours

3. Has had a kidney transplant within previous 30 days

4. Has had a liver transplant within previous 1 year

5. Has had a stem cell transplant within previous 1 year

6. Has had therapeutic hypothermia within previous 24 hours

7. Has had plasmapheresis within the previous 24 hours

8. Has a Ventricular Assist Device

9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Gender: All

Minimum Age: N/A

Maximum Age: 20 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Chi Hornik Principal Investigator Duke Clinical Research Institute
Overall Contact

Last Name: Chi Hornik

Phone: (919) 260-7626

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup:
Arkansas Children's Hospital Research Institute | Little Rock, Arkansas, 72202, United States Recruiting D Ann Pierce 501-364-4440 [email protected]
Colorado University Denver | Aurora, Colorado, 80045, United States Recruiting Peter Mourani 303-724-2390 [email protected]
Alfred I. DuPont Hospital for Children | Wilmington, Delaware, 19803, United States Recruiting Ramany John 302-298-7521 [email protected]
University of Florida Jacksonville Shands Medical Center | Jacksonville, Florida, 32209, United States Recruiting Alexandrea Borges 904-244-2266 [email protected]
Kapiolani Womens and Childrens Medical Center | Honolulu, Hawaii, 96826, United States Recruiting Prashant Purohit 808-983-6000
Ann and Robert H. Lurie Childrens Hospital of Chicago | Chicago, Illinois, 60614, United States Recruiting Laura Fearn 312-227-6280 [email protected]
Riley Hospital for Children at Indiana University | Indianapolis, Indiana, 46202, United States Recruiting Ashley Moore 317-278-7858 [email protected]
University of Kansas Medical Center | Kansas City, Kansas, 66160, United States Recruiting Kristina Foster 913-588-6393 [email protected]
Wesley Medical Center | Wichita, Kansas, 67214, United States Recruiting Paula Delmore 316-962-8555 [email protected]
University of Louisville Norton Childrens Hospital | Louisville, Kentucky, 40202, United States Recruiting Andrew Michael 502-629-8362 [email protected]
Tulane University Health Science Center | New Orleans, Louisiana, 70112, United States Recruiting Amy Katz 504-988-2566 [email protected]
Ochsner Baptist Clinical Trials Unit | New Orleans, Louisiana, 70115, United States Recruiting Ellen Lovell 504-897-5882 e[email protected]
University of Minnesota | Minneapolis, Minnesota, 55455, United States Recruiting Catherine Bendel 612-626-3250 [email protected]
University of Mississippi Medical Center | Jackson, Mississippi, 39216, United States Recruiting Joy Holmes 601-815-4179 [email protected]
Childrens Mercy Hospital | Kansas City, Missouri, 64111, United States Recruiting Megan Bledsoe 816-960-3007 [email protected]
University of Nebraska Medical Center | Omaha, Nebraska, 68114, United States Recruiting Rachel Wellman 402-552-9878 [email protected]
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire, 03756, United States Recruiting J. Jarvis 603-653-9064 [email protected]
University of New Mexico Health Science Center | Albuquerque, New Mexico, 87131, United States Recruiting Olivia Nunez 505-272-9898 [email protected]
Kravis Children's Hospital at Mt. Sinai | New York, New York, 10029, United States Recruiting Iris Mandell 212-241-6489 [email protected]
University of North Carolina at Chapel Hill | Chapel Hill, North Carolina, 27599, United States Recruiting Jennifer Talbert 984-974-7865 [email protected]
Duke University Health System | Durham, North Carolina, 27710, United States Recruiting Melissa Harward [email protected]
Cincinnati Childrens Hospital Medical Center | Cincinnati, Ohio, 45229, United States Recruiting Cassie Kirby 513-803-5332 [email protected]
Board of Regents of the University of Oklahoma | Oklahoma City, Oklahoma, 73104, United States Recruiting Christi Madden 405-271-4407 44265 [email protected]
Oregon Health and Science University | Portland, Oregon, 97239, United States Recruiting Kira Clark 503-418-8112 [email protected]
Rhode Island Hospital | Providence, Rhode Island, 02903, United States Recruiting Barbara Bancroft 401-444-2884 [email protected]
Medical University of South Carolina Children's Hospital | Charleston, South Carolina, 29425, United States Recruiting Layla Al Sarraf 843-876-5203 [email protected]
University of South Carolina | Columbia, South Carolina, 29203, United States Recruiting Tyler Singleton 803-216-3377 [email protected]
Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville, Tennessee, 37232, United States Recruiting Theresa Rogers 615-343-6312 [email protected]
Dell Children's Medical Center of Central Texas | Austin, Texas, 78723, United States Recruiting LeeAnn Christie 512-324-0000 86529 [email protected]
Seattle Children's Hospital | Seattle, Washington, 98105, United States Recruiting Megan Kelton 206-987-5539 megan.keltonr[email protected]
University Wisconsin | Madison, Wisconsin, 53705, United States Recruiting Maria Stanley 608-890-3137 [email protected]
Medical College of Wisconsin | Milwaukee, Wisconsin, 53226, United States Recruiting Sadaf Shad 414-266-7426 [email protected]
Children's Hospital of Eastern Ontario | Ottawa, Ontario, Canada Recruiting Daniela Pohl 613-737-7600 [email protected]
The Hospital for Sick Children | Toronto, Ontario, Canada Recruiting Yaron Finkelstein 416-813-5317 [email protected]
CHU Sainte-Justine | Montréal, Quebec, Canada Recruiting Julie Autmizguine 514-582-4147 [email protected]
Location Countries

Canada

United States

Verification Date

October 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Children and young adults who are prescribed drugs of interest

Description: Children and young adults who are prescribed drugs of interest as part of their routine medical care OR are SARS-CoV-2 positive.

Acronym POPS or POP02
Patient Data No
Study Design Info

Observational Model: Other

Time Perspective: Prospective

Source: ClinicalTrials.gov