Evidence map›Paper›PMID 37606870›Full record

Trial reportClinical drug investigation2023

OCE-205, A Novel, Selective Vasopressin Receptor Mixed Agonist-Antagonist: Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics from a Phase 1 Study in Healthy Volunteers.

Yu Bagger, William R Ravis, Geoff Harris, Stan Bukofzer

Open access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in Clinical drug investigation, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 31% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Review
  2. OCE-205 in rats and non-human primates: Pharmacokinetic and pharmacodynamic analysis.Current research in pharmacology and drug discovery · 2023
    Article
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

4 authors at 2 institutions in 2 countries.

Yu BaggerFerring Pharmaceuticals A/S, Copenhagen, Denmark.
William R RavisOcelot Bio, Inc., 601 Marshall Street, Redwood City, CA, 94063, USA.
Geoff HarrisOcelot Bio, Inc., 601 Marshall Street, Redwood City, CA, 94063, USA.
Stan BukofzerOcelot Bio, Inc., 601 Marshall Street, Redwood City, CA, 94063, USA. stan@ocelotbio.com.ORCID http://orcid.org/0009-0007-5545-8210
Ferring Pharmaceuticals (Denmark) · DKOcera Therapeutics (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOCE-205, a novel, selective vasopressin V1a receptor mixed agonist/antagonist with no V2 receptor activity, may treat the portal hypertension-related complications of end-stage liver disease with an improved therapeutic profile over currently utilized nonselective full-agonist vasopressin analogs.

objectivesThis Phase 1, double-blind, placebo-controlled, within-dose-group randomized trial investigated the safety, tolerability, and pharmacokinetic/pharmacodynamic profiles of OCE-205 in healthy adults.

methodsSubjects received a single intravenous dose of OCE-205 0.1, 0.3, 0.45, 0.6, or 0.9 mg, or placebo infused over 6 h. Safety and tolerability were assessed, and blood samples were obtained for pharmacokinetic analyses. Sixty-four subjects were randomized and treated.

resultsArea under the concentration-time curve (AUC) and maximum plasma concentrations (C

conclusionOCE-205 was safe and well tolerated, with a pharmacodynamic profile achieving submaximal partial agonism consistent with mixed agonism-antagonism of the V1a receptor. OCE-205 shows promise as a treatment for some complications of end-stage liver disease.

Indexed as

End Stage Liver DiseaseHypertensionPeptidesAdultArea Under CurveBlood PressureDose-Response Relationship, DrugDouble-Blind MethodHealthy VolunteersHumansReceptors, VasopressinOCE-205PeptidesReceptors, Vasopressin

Identifiers

PMID37606870
PMCPMC10514109
OpenAlexW4386046081

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.