IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Dis… (NCT06324396) | Clinical Trial Compass
RecruitingPhase 1
IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease
United States15 participantsStarted 2024-03-01
Plain-language 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.
Who can participate
Age range8 Years
SexALL
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:
* \> 8 years
* Status Post Fontan Completion
* Ability to provide informed permission-assent (\<18 years) or consent (≥18 years)
* Fasting overnight (\~8 hours)
Exclusion Criteria:
* 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
What they're measuring
1
Sildenafil concentration as measured by area under the curve (AUC)
Timeframe: 2 years
2
Pravastatin concentration as measured by area under the curve (AUC)