Evidence map›Paper›PMID 38761014›Full record

Trial reportClinical and translational science2024

First-in-human safety, tolerability, and pharmacokinetic results of DFV890, an oral low-molecular-weight NLRP3 inhibitor.

Ewa Gatlik, Beata Mehes, Emilie Voltz, Ulrike Sommer, Elaine Tritto, Giulia Lestini, Xiaoxi Liu, Parasar Pal, Maria Velinova, Wiliam S Denney and 4 more

Abstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in Clinical and translational science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing 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.

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

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

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  16. Toward targeting of inflammasome signaling in venous thrombosis.Journal of thrombosis and haemostasis : JTH · 2025
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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

14 authors.

Ewa GatlikBiomedical Research, Novartis Pharma AG, Basel, Switzerland.ORCID 0000-0002-1258-2840
Beata MehesBiomedical Research, Novartis Pharma AG, Basel, Switzerland.
Emilie VoltzBiomedical Research, Novartis Pharma AG, Basel, Switzerland.ORCID 0009-0003-8965-8369
Ulrike SommerBiomedical Research, Novartis Pharma AG, Basel, Switzerland.ORCID 0009-0002-6698-0884
Elaine TrittoBiomedical Research, Novartis Pharma AG, Basel, Switzerland.ORCID 0009-0003-3769-8190
Giulia LestiniNovartis Pharma AG, Basel, Switzerland.ORCID 0009-0003-8904-7429
Xiaoxi LiuNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Parasar PalNovartis Healthcare Pvt. Ltd, Hyderabad, India.ORCID 0009-0006-9493-4155
Maria VelinovaICON plc, Groningen, The Netherlands.ORCID 0009-0003-8655-3174
Wiliam S DenneyHuman Predictions LLC, Cambridge, Massachusetts, USA.ORCID 0000-0002-5759-428X
Yunlin FuNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.ORCID 0000-0003-2988-4447
Anthony OpipariIFM Therapeutics, Boston, Massachusetts, USA.
Dennis DeanIFM Therapeutics, Boston, Massachusetts, USA.
Guido JungeBiomedical Research, Novartis Pharma AG, Basel, Switzerland.ORCID 0000-0002-8938-3612

Funding

IFM Therapeutics
6 · The paper itself

Abstract

This first-in-human study evaluated the safety, tolerability, single- and multiple-dose pharmacokinetic profiles with dietary influence, and pharmacodynamics (PD) of DFV890, an oral NLRP3 inhibitor, in healthy participants. In total, 122 participants were enrolled into a three-part trial including single and 2-week multiple ascending oral doses (SAD and MAD, respectively) of DFV890, and were randomized (3:1) to DFV890 or placebo (SAD [3-600 mg] and MAD [fasted: 10-200 mg, once-daily or fed: 25 and 50 mg, twice-daily]). DFV890 was generally well-tolerated. Neither deaths nor serious adverse events were reported. A less than dose-proportional increase in exposure was observed with the initially used crystalline suspension (3-300 mg); however, an adjusted suspension formulation using spray-dried dispersion (SDD; 100-600 mg) confirmed dose-proportional increase in exposure. Relative bioavailability between crystalline suspension and tablets, and food effect were evaluated at 100 mg. Under fasting conditions, C

Indexed as

Dose-Response Relationship, DrugInterleukin-1betaNLR Family, Pyrin Domain-Containing 3 ProteinAdministration, OralAdolescentAdultBiological AvailabilityDouble-Blind MethodDrug Administration ScheduleFemaleFood-Drug InteractionsHealthy VolunteersHumansMaleMiddle AgedYoung AdultIL1B protein, humanInterleukin-1betaNLR Family, Pyrin Domain-Containing 3 ProteinNLRP3 protein, human

Identifiers

PMID38761014
PMCPMC11101992

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Registered trials

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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.