Evidence map›Paper›PMID 34046921›Full record

Trial reportBritish journal of clinical pharmacology2022

First-in-human trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of STR-324, a dual enkephalinase inhibitor for pain management.

Laurence M Moss, Cecile L Berends, Emilie M J van Brummelen, Ingrid M C Kamerling, Erica S Klaassen, Kirsten Bergmann, Vanessa Ville, Victor Juarez-Perez, Annie-Claude Benichou, Geert Jan Groeneveld

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.7field-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

7 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Article
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  4. Review
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  7. 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

10 authors at 3 institutions in 2 countries.

Laurence M MossCentre for Human Drug Research, Leiden, the Netherlands.ORCID 0000-0001-6182-0553
Cecile L BerendsCentre for Human Drug Research, Leiden, the Netherlands.ORCID 0000-0001-8721-4682
Emilie M J van BrummelenCentre for Human Drug Research, Leiden, the Netherlands.ORCID 0000-0002-6526-4790
Ingrid M C KamerlingCentre for Human Drug Research, Leiden, the Netherlands.
Erica S KlaassenCentre for Human Drug Research, Leiden, the Netherlands.
Kirsten BergmannCentre for Human Drug Research, Leiden, the Netherlands.
Vanessa VilleStragen France, Lyon, France.
Victor Juarez-PerezStragen France, Lyon, France.
Annie-Claude BenichouStragen Services, Lyon, France.
Geert Jan GroeneveldCentre for Human Drug Research, Leiden, the Netherlands.ORCID 0000-0002-4655-6667
Leiden University · NLCentre for Human Drug Research · NLStragen (France) · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimDual enkephalinase inhibitors (DENKIs) are involved in the regulation of nociception via opioid receptors. The novel compound STR-324 belongs to the DENKI pharmacological class. This first-in-human study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of STR-324 in healthy male participants.

methodsThis was a randomised, double-blind, placebo-controlled ascending dosing study in two parts: in part 1, 30 participants received 0.004-11.475 mg h

resultsNo clinically relevant changes in safety parameters were observed. All treatment-emergent adverse events were mild and transient. The pharmacokinetics of STR-324 could not be determined due to most concentrations being below quantifiable limits. STR-324 metabolite concentrations were measurable, showing dose proportionality of C

conclusionSTR-324 displayed favourable safety and tolerability profiles at all doses up to 11.475 mg h TRIAL REGISTRY: EudraCT (2014-002402-21) and toetsingonline.nl (63085).

Indexed as

NeprilysinPain ManagementArea Under CurveDose-Response Relationship, DrugDouble-Blind MethodHealthy VolunteersHumansMaleNeprilysinDENKIdual enkephalinase inhibitorfirst-in-humanopioidspain managementphase 1

Identifiers

PMID34046921
PMCPMC9292820
OpenAlexW3164071874

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.