A Pharmacokinetic Study of Intravenous and Intranasal Oxytocin in Healthy Subjects
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to sample blood and model the plasma pharmacokinetics (PK)
      of a single dose of intravenous (IV) oxytocin and a single dose of intranasal (i.n.)
      oxytocin.

      This is an unblinded study of subjects, all of whom will receive an intravenous (IV) infusion
      and intranasal (i.n.) dose of oxytocin (a naturally occurring hormone that is made in the
      brain) with blood samples taken thereafter in order to create a formula to describe the
      concentrations of oxytocin in the blood over time (pharmacokinetics).

      In this study healthy volunteers and people are recruited for a two day study. Each study
      participant will have 2 IV catheters placed (one in each arm) for the day of IV oxytocin
      dosing and 1 IV catheter on the day of i.n. oxytocin dosing. After placement of the IV
      catheters, an infusion of oxytocin will be given over a 30 minute period. Blood samples will
      be taken after the infusion begins and several times during and after the infusion. The blood
      will be drawn through the IV catheter not used for the oxytocin infusion. For the intranasal
      oxytocin administration day, 1 IV catheter will be placed and several blood samples will be
      taken after administration.
    

Detailed description: 
      This is an unblinded, sequential study of subjects; all participants will receive an infusion
      of oxytocin and intranasal administration of oxytocin with blood samples taken thereafter in
      order to create a formula to describe the concentrations of oxytocin in the blood over time
      (pharmacokinetics). In this study healthy volunteers. Participants will come to the Clinical
      Research Unit (CRU) on study day 1 and have two IVs inserted; one in each arm. Participants
      will get a 30 minute infusion through one of the IV catheters of oxytocin and blood will be
      taken several times over the next 120 minutes, plasma separated, and the amount of oxytocin
      measured in the plasma samples. Participants will come to the CRU on study day 2 and have one
      IV inserted; in the arm. Participants will self administer intranasal oxytocin and blood will
      be taken several times over the next 60 minutes and the amount of oxytocin measured in the
      plasma samples. This information will be analyzed by another group at Stanford University
      under a data sharing agreement between the institutions and funded by a grant from the
      National Institutes of Health. Compartmental modeling will be performed using NONMEM to
      describe the change in oxytocin concentrations over time. The effect of subject age, sex,
      race, ethnicity and weight on the pharmacokinetics of oxytocin will be examined, since these
      factors can affect pharmacokinetics and are important to better adjust the dose of drug to
      the individual.

      The main purpose of this study is to determine the amount of oxytocin in plasma after IV and
      i.n. administration.

      The research participants will not benefit from this study, but the knowledge investigators
      get will be important to adjust oxytocin dose to individuals, and to be able to calculate
      plasma oxytocin concentrations after various doses in the future. The sample size chosen is
      needed to get an accurate estimate for the parameters in the pharmacokinetic model for the
      population, not just the subjects in this study.
    

Intervention name(s): intravenous oxytocin; intranasal oxytocin
Intervention type(s): Drug; Drug
Intervention description(s): Oxytocin given by intravenous route; Oxytocin given by intranasal administration
Other intervention name(s): Pitocin; Pitocin
Intervention MeSH terms: Oxytocin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Each subject will receive 14 micrograms of oxytocin intravenously over 30 minutes and 102 micrograms of oxytocin intranasally.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Acute Pain; Chronic Pain; Intravenous Oxytocin; Intranasal Oxytocin