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 range

17 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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)

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