RecruitingPhase 1NCT06324396
IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease
Sponsor
Children's Mercy Hospital Kansas City
Enrollment
15 participants
Start Date
Mar 1, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
This is a single center, open-label, prospective, investigation to quantify the effects liver congestion and fibrosis has on hepatic drug metabolism and transport in children, adolescents, and young adults with Fontan circulation.
Eligibility
Min Age: 8 Years
Inclusion Criteria4
- > 8 years
- Status Post Fontan Completion
- Ability to provide informed permission-assent (<18 years) or consent (≥18 years)
- Fasting overnight (~8 hours)
Exclusion Criteria9
- Pregnancy
- Non-fasting
- Non-removable metal in body or where magnetic resonance imaging (MRI) is considered unsafe
- Sildenafil and/or Pravastatin therapy within last 2 months
- History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter Sildenafil and Pravastatin disposition (absorption, metabolism, distribution, or clearance)
- Pharmacotherapy that interacts with Sildenafil (cytochrome P450 3A4 and P450 3A5 (CYP3A4/5) inducers/inhibitors) and/or Pravastatin (organic anion transporting polypeptide (OATP1B1) inducers/inhibitors)
- Inability to swallow a tablet
- >5X the age-specific upper limit of normal for aspartate aminotransferase (AST) and alanine aminotransferase (ALT), total and conjugated bilirubin
- Diarrhea in the last 24 hours *History of solid organ transplantation
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Interventions
DRUGSildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg)
A single oral dose of sildenafil will be administered to all study subjects.
DRUGPravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years)
A single oral dose of pravastatin will be administered to all study subjects.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06324396