A Phase IV, Two-part, Open-label Study Assessing the Pharmacokinetics, Safety and Pharmacodynamics of Spironolactone Oral Suspension in Pediatric Patients

PHASE4UnknownINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

June 30, 2024

Primary Completion Date

March 31, 2025

Study Completion Date

March 31, 2025

Conditions
Edema Due to Heart Failure or Cirrhosis
Interventions
DRUG

Spironolactone Oral Suspension

"Spironolactone will be dosed on a mg/kg basis, with actual weight on Day 1 (pre-dose) determining the spironolactone suspension volume administered. Therefore, for a given patient, the dose administered on Day 1, based on the weight measured on Day 1, will be administered throughout their participation in the study.~Spironolactone will be administered as a single dose in the single-dose periods (Group 4, Parts 1 and 2), and as QD dosing in the multiple-dose periods (Groups 1 to 4, Parts 1 and 2).~The low and high doses to be administered during Part 2 of the study will be determined by the Safety Review Committee following their review of Part 1 data."

Sponsors
All Listed Sponsors
lead

CMP Development, LLC

INDUSTRY