Evidence map›Paper›PMID 40121179›Full record

Trial reportBritish journal of anaesthesia2025

Plasma pharmacokinetics of intravenous and intranasal oxytocin in nonpregnant adults.

Steven L Shafer, Douglas G Ririe, Scott Miller, Regina S Curry, David T Hsu, Gregory M Sullivan, James C Eisenach

2 registry-linked trialsAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of anaesthesia, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03929367 phase4completednot on this map

Pharmacokinetics of Intravenous Oxytocin and Effects on Sensory Function in Healthy Volunteers

TypeinterventionalSponsorWake Forest University Health SciencesRan2019 to 2020Enrolled11ConditionsChronic PainArmsOxytocin
NCT05672667 phase1completednot on this map

A Pharmacokinetic Study of Intravenous and Intranasal Oxytocin in Healthy Subjects

TypeinterventionalSponsorWake Forest University Health SciencesRan2023 to 2023Enrolled25ConditionsHealthy Volunteer StudyArmsintravenous oxytocin, intranasal oxytocin
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Steven L ShaferDepartment of Anesthesiology, Critical Care and Pain Medicine, Stanford University, Palo Alto, CA, USA. Electronic address: steven.shafer@stanford.edu.
Douglas G RirieDepartment of Anesthesiology, Advocate Health Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Scott MillerDepartment of Anesthesiology, Advocate Health Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Regina S CurryDepartment of Anesthesiology, Advocate Health Wake Forest University School of Medicine, Winston-Salem, NC, USA.
David T HsuTonix Pharmaceuticals, Inc., Chatham, NJ, USA.
Gregory M SullivanTonix Pharmaceuticals, Inc., Chatham, NJ, USA.
James C EisenachDepartment of Anesthesiology, Advocate Health Wake Forest University School of Medicine, Winston-Salem, NC, USA.

Funding

Pharmacokinetics/Pharmacodynamics CoreP01NS119159 · NINDS · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI James Eisenach · 2022 to 2026
$10.4M
NINDS NIH HHS P01 NS119159
6 · The paper itself

Abstract

backgroundThe development of oxytocin as a therapeutic agent outside of obstetrics has been hampered by antibody-based assays that lack specificity, leading to inconsistent and incompletely reported pharmacokinetic models to guide drug dosing. This study describes the population plasma pharmacokinetics of intravenous and intranasal oxytocin using a sensitive and specific liquid chromatography-tandem mass spectroscopy (LC/MS) assay.

methodsTwo studies in healthy adult men and nonpregnant women were performed, the first with intravenous oxytocin 16.7 μg over 1 or 10 min and the second with intravenous oxytocin 13.7 μg over 30 min and, on a separate day, intranasal oxytocin 100 μg (n=24). Venous plasma oxytocin concentration was measured using LC/MS and enzyme-linked immunosorbent assay. Pharmacokinetic parameters were estimated using NONMEM.

resultsThe pharmacokinetics of intravenous oxytocin were well described by a two-compartment model (0% bias, 18% median inaccuracy). The two-compartment model for intranasal oxytocin was characterised by substantial subject-to-subject variability (9% median bias, 47% median inaccuracy). Nasal oxytocin bioavailability was 0.7%. Oxytocin samples assayed with LC/MS were systematically higher than simultaneous samples assayed with enzyme-linked immunosorbent assay.

conclusionsThe pharmacokinetics of intravenous oxytocin are well described by a two-compartment model. The low bioavailability (<1%) and large intersubject variability in plasma oxytocin after intranasal dosing could partially explain the inconsistent reports of oxytocin efficacy in the clinical literature with this delivery method. A publicly available simulator was created to guide oxytocin dosing in future studies. CLINICAL

trial registrationNCT03929367 (Study 1) and NCT05672667 (Study 2).

Indexed as

OxytocicsOxytocinAdministration, IntranasalAdministration, IntravenousAdultBiological AvailabilityChromatography, LiquidFemaleHumansMaleMiddle AgedTandem Mass SpectrometryYoung AdultOxytocicsOxytocinintranasalintravenousNONMEMoxytocinpharmacokinetics

Identifiers

PMID40121179
PMCPMC12106900

What OpenQuestion holds

Textmetadata
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.