Clinical Trial: Pharmacokinetics of Sildenafil in Premature Infants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Pharmacokinetics of Sildenafil in Premature Infants

Brief Summary: The purpose of this study is to learn more about the safety and dosing of sildenafil in infants.

Detailed Summary: Pharmacokinetics and safety of sildenafil will be studied in preterm infants who are receiving sildenafil per standard of care or 1 dose prescribed for the study.
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome:

  • Area under the plasma concentration versus time curve 0-24 hours for sildenafil [ Time Frame: IV study dose 0-15 min,1-2,3-4,12-14,24-30,48-56hr after flush.Clinical care: IV <0.5hr before dose <15 min & 3-4hr after flush <0.5hr before next dose. Enteral <0.5hr before dose, 1-2 & 3-4hr after dose, <0.5hr before next dose. 22-26hr after last dose ]
  • Peak plasma concentration of sildenafil [ Time Frame: IV study dose 0-15 min,1-2,3-4,12-14,24-30,48-56hr after flush.Clinical care: IV <0.5hr before dose <15 min & 3-4hr after flush <0.5hr before next dose. Enteral <0.5hr before dose, 1-2 & 3-4hr after dose, <0.5hr before next dose. 22-26hr after last dose ]
  • Clearance of sildenafil [ Time Frame: IV study dose 0-15 min,1-2,3-4,12-14,24-30,48-56hr after flush.Clinical care: IV <0.5hr before dose <15 min & 3-4hr after flush <0.5hr before next dose. Enteral <0.5hr before dose, 1-2 & 3-4hr after dose, <0.5hr before next dose. 22-26hr after last dose ]
  • Volume of distribution at steady state [ Time Frame: IV study dose 0-15 min,1-2,3-4,12-14,24-30,48-56hr after flush.Clinical care: IV <0.5hr before dose <15 min & 3-4hr after flush <0.5hr before next dose. Enteral <0.5hr before dose, 1-2 & 3-4hr after dose, <0.5hr before next dose. 22-26hr after last dose ]
  • Half life of sildenafil [ Time Frame: IV study dose 0-15 min,1-2,3-4,12-14,24-30,48-56hr after flush.Clinical care: IV <0.5hr before dose <15 min & 3-4hr after flush <0.5hr before next dose. Enteral <0.5hr before dose, 1-2 & 3-4hr after dose, <0.5hr before next dose. 22-26hr after last dose ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of subjects with adverse events as a measure of safety and tolerability. [ Time Frame: From the time of the first dose to 3 days after the last dose; serious adverse events will be collected from the first dose of sildenafil to 7 days after the last dose of sildenafil ]
  • Correlation between serum and dried blood spot samples [ Time Frame: 1-7 days ]
  • Evaluate P450 single nucleotide polymorphisms (SNPs) [ Time Frame: 2-7 days ]


Original Secondary Outcome:

  • Number of subjects with adverse events as a measure of safety and tolerability. [ Time Frame: From the time of the first dose to 3 days after the last dose; serious adverse events will be collected from the first dose of rifampin to 7 days after the last dose of sildenafil ]
  • Correlation between serum and dried blood spot samples [ Time Frame: 1-7 days ]
  • Evaluate P450 single nucleotide polymorphisms (SNPs) [ Time Frame: 2-7 days ]


Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: August 17, 2012
Date Started: February 2013
Date Completion:
Last Updated: November 1, 2016
Last Verified: November 2016