Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care

About the Study

Currently Recruiting: Participants

Study Drug/Intervention: Spirnolactone or eplerepnone

Study Timeline: This study is expected to conclude in April 2024.

Visit the Study Website

ClinicalTrials.gov ID: NCT04278404


Study Objective

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.

Inclusion & Exclusion Criteria

Inclusion Criteria:

  1. Participant is < 21 years of age
  2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:
  3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment 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

Exclusion Criteria:

  1. Participant has a known pregnancy Below exclusion criteria apply only to participants receiving one or more of the study drugs of interest at the time of enrollment,
  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


  • The Emmes Company, LLC

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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