Pharmacokinetics of Sildenafil in Premature Infants

This study has been completed.
Sponsor:
Collaborators:
Duke University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The EMMES Corporation
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01670136
First received: August 17, 2012
Last updated: November 1, 2016
Last verified: November 2016

August 17, 2012
November 1, 2016
February 2013
July 2016   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01670136 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Pharmacokinetics of Sildenafil in Premature Infants
Pharmacokinetics of Sildenafil in Premature Infants
The purpose of this study is to learn more about the safety and dosing of sildenafil in infants.
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.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Persistent Pulmonary Hypertension of the Newborn
Drug: 1 dose of sildenafil
A single IV dose of sildenafil will be administered over 90 minutes with no greater than a 15-minute flush. Final dose to be determined based on at least the first 4 participants enrolled in Cohort 1; final dose expected to be a single dose between 0.25 and 0.5 mg/kg.
Other Names:
  • Revatio
  • Viagra
  • No Intervention: sildenafil, standard of care
    Infants receiving sildenafil as standard of care
  • sildenafil administered for study
    1 dose of sildenafil administered for study
    Intervention: Drug: 1 dose of sildenafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
July 2016
July 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Cohort 1:

  • Gestational age 28 weeks or less receiving sildenafil as standard of care < 365 postnatal days

Cohort 2:

  • Gestational age 28 weeks or less
  • 7-28 postnatal days of age
  • Mechanical ventilation or nasal continuous positive airway pressure (NCPAP) or high-flow nasal cannula
  • Intravenous line in place

Exclusion Criteria:

Cohort 1:

  • Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study

Cohort 2:

  • Previous exposure to sildenafil within 7 days prior to enrollment
  • Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study
  • History of allergic reactions to sildenafil
  • AST > ULN or ALT > 3x ULN
  • Currently on a vasopressor for hypotension
  • Known sickle cell disease
Sexes Eligible for Study: All
up to 364 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01670136
11-1646, HHSN27500014
Yes
Not Provided
No
Not Provided
University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
  • Duke University
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • The EMMES Corporation
Principal Investigator: Matthew M Laughon, MD, MPH University of North Carolina
University of North Carolina, Chapel Hill
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP