Evidence map›Paper›PMID 34961905›Full record

Trial reportClinical pharmacokinetics2022

Transition from Syringe to Autoinjector Based on Bridging Pharmacokinetics and Pharmacodynamics of the P2Y

Isabelle Zenklusen, Chih-Hsuan Hsin, Uta Schilling, Martin Kankam, Andreas Krause, Mike Ufer, Jasper Dingemanse

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04557280 (A Randomized, Open-label, 3-period Cross-over Study to Assess the Pharmacokinetics of Selatogrel), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 37% 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.

NCT04557280 phase1completednot on this map

A Randomized, Open-label, 3-period Cross-over Study to Assess the Pharmacokinetics of Selatogrel (ACT-246475) in Healthy Subjects After Subcutaneous Administration by Syringe and Auto-injector

TypeinterventionalSponsorViatris Innovation GmbHRan2020 to 2020Enrolled24ConditionsHealthy SubjectsArmsSelatogrel
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. 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

7 authors at 2 institutions in 2 countries.

Isabelle ZenklusenDepartment of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123, Allschwil, Switzerland. isabelle.zenklusen@idorsia.com.ORCID 0000-0002-8106-8087
Chih-Hsuan HsinDepartment of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123, Allschwil, Switzerland.
Uta SchillingDepartment of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123, Allschwil, Switzerland.
Martin KankamAltasciences Clinical, Inc. 10103 Metcalf Avenue, Overland Park, KS 66212, USA.
Andreas KrauseDepartment of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123, Allschwil, Switzerland.
Mike UferDepartment of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123, Allschwil, Switzerland.
Jasper DingemanseDepartment of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123, Allschwil, Switzerland.
Idorsia (Switzerland) · CHAltasciences Clinical Research Vince & Associates · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesSelatogrel is a potent, reversible, and selective antagonist of the platelet P2Y

methodsThis was a single-center, randomized, open-label, three-period, cross-over Phase I study in 24 healthy subjects. In each period, a single subcutaneous dose of 16 mg selatogrel was administered as (1) a Phase III liquid formulation by autoinjector (Treatment A), (2) a Phase III liquid formulation by prefilled syringe (Treatment B), or (3) a Phase I/II reconstituted lyophilizate-based formulation by syringe (Treatment C). PK parameters including area under the plasma concentration-time curve from zero to infinity (AUC

resultsComparing Treatment A to Treatment C, the exposure (AUC

conclusionsPK and simulated PD effects of selatogrel were similar across treatments. CLINICAL

trial registrationNCT04557280.

Indexed as

OrganophosphonatesSyringesArea Under CurveCross-Over StudiesHealthy VolunteersHumansPyrimidinesTherapeutic EquivalencyOrganophosphonatesPyrimidinesselatogrel

Identifiers

PMID34961905
OpenAlexW4200404143

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.