Study: NCT06021860

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Spironolactone Oral Suspension
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Spironolactone Oral Suspension
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Spironolactone Oral Suspension
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Spironolactone Oral Suspension
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Spironolactone Oral Suspension
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Spironolactone Oral Suspension
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Spironolactone Oral Suspension
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Spironolactone Oral Suspension
Description: 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.