UnknownPhase 4

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

96 participantsStarted 2024-06

Plain-language summary

This is a 2-part, 2 periods per part, open-label study with spironolactone oral suspension in pediatric patients with edema due to HF or hepatic cirrhosis. Both study parts will evaluate the safety, PK and PD of multiple doses of spironolactone in patients aged from birth to ≤17 years of age.

Who can participate

Age range17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient or patient's parent or legal guardian (if applicable) provides written consent to participate in the study and provides written informed consent prior to any study procedures being performed. * Female patients of childbearing potential may be enrolled if they are practicing abstinence and have a negative urine pregnancy test at Screening and/or Day 1, or using 2 forms of highly effective contraception. * Male patients with female partners of childbearing potential may be enrolled if they are practicing abstinence or using 2 forms of highly effective contraception. * Patients must agree to stay in clinic or the supervised care unit on specified days. * Patients must have past diagnosis of edema (includes peripheral and/or pulmonary edema) due to heart failure or hepatic cirrhosis requiring, or expected to require, treatment with spironolactone in the investigator's judgment. * Stable therapy for chronic comorbidities (unrelated to HF or cirrhosis, and as approved by the Investigator and Medical Monitor) is allowed, with no changes to these medications in the 72 hours prior to administration of study drug on Day 1 and for the duration of the study. * Loop diuretics (such as furosemide), if taken, must be stable for 72 hours prior to dosing of spironolactone on Day 1 and to the extent possible for the remainder of the study. Exclusion Criteria: * Prematurity, defined as babies not born out of full-term pregnancy (Group 4 only) (˂38 weeks of gesta…

What they're measuring

Part 1: Absorption rate constant (Ka) of spironolactone (time^-1) in the multiple-dose period

Timeframe: Pre-dose (Day 1) to 22-26 hours post-dose (Day 11)

Part 2: Absorption rate constant (Ka) of spironolactone (time^-1) in the multiple-dose period

Timeframe: Pre-dose (Day 1) to 22-26 hours post-dose (Day 11)

Part 1: Total clearance from plasma after oral administration (CL/F) of spironolactone in the multiple-dose period

Timeframe: Pre-dose (Day 1) to 22-26 hours post-dose (Day 11)

Part 2: Total clearance from plasma after oral administration (CL/F) of spironolactone in the multiple-dose period

Timeframe: Pre-dose (Day 1) to 22-26 hours post-dose (Day 11)

Part 1: Volume of distribution after oral administration (V/F) of spironolactone in the multiple-dose period

Timeframe: Pre-dose (Day 1) to 22-26 hours post-dose (Day 11)

Part 2: Volume of distribution after oral administration (V/F) of spironolactone in the multiple-dose period

Timeframe: Pre-dose (Day 1) to 22-26 hours post-dose (Day 11)

Part 1: Total clearance from plasma after oral administration (CL/F) of canrenone in the multiple-dose period

Trial details

NCT IDNCT06021860

SponsorCMP Development, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03

Contact for this trial

Paul Sudhakar, M.Pharm

816-507-8249 pauls@ptspharma.com

View on ClinicalTrials.gov More Edema Due to Heart Failure or Cirrhosis trials