Pharmacokinetics of Sildenafil in Premature Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborators:
Duke University
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: March 5, 2014
Last verified: March 2014

August 17, 2012
March 5, 2014
February 2013
November 2014   (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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
  • Correlation between serum and dried blood spot samples [ Time Frame: 1-7 days ] [ Designated as safety issue: No ]
  • Evaluate P450 single nucleotide polymorphisms (SNPs) [ Time Frame: 2-7 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Correlation between serum and dried blood spot samples [ Time Frame: 1-7 days ] [ Designated as safety issue: No ]
  • Evaluate P450 single nucleotide polymorphisms (SNPs) [ Time Frame: 2-7 days ] [ Designated as safety issue: No ]
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
Endpoint Classification: Pharmacokinetics/Dynamics Study
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 0.75 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.
 
Recruiting
41
May 2015
November 2014   (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
Both
up to 364 Days
No
Contact: Matthew M Laughon, MD, MPH 919-966-5063 matt_laughon@med.unc.edu
Contact: Maurine Morris 919-668-8349 maurine.morris@duke.edu
United States
 
NCT01670136
11-1646
Yes
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
March 2014

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