Evidence map›Paper›PMID 35172043›Full record

Trial reportClinical pharmacology in drug development2022

Pharmacokinetics and Macrophage Inhibitory Cytokine-1 Pharmacodynamics of the Murine Double Minute 2 Inhibitor, Navtemadlin (KRT-232) in Fed and Fasted Healthy Subjects.

Shekman Wong, Cecile Krejsa, Dana Lee, Anna Harris, Emilie Simard, Xiaohui Wang, Martine Allard, Terry Podoll, Terry O'Reilly, J Greg Slatter

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical pharmacology in drug development, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 35% 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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Article
  3. 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

10 authors at 6 institutions in 1 country.

Shekman WongKartos Therapeutics, Inc, Redwood City, CA and, Bellevue, Washington, USA.
Cecile KrejsaKartos Therapeutics, Inc, Redwood City, CA and, Bellevue, Washington, USA.
Dana LeeKartos Therapeutics, Inc, Redwood City, CA and, Bellevue, Washington, USA.
Anna HarrisKartos Therapeutics, Inc, Redwood City, CA and, Bellevue, Washington, USA.
Emilie SimardCertara Strategic Consulting, Princeton, New Jersey, USA.
Xiaohui WangCertara Strategic Consulting, Princeton, New Jersey, USA.
Martine AllardCertara Strategic Consulting, Princeton, New Jersey, USA.
Terry PodollIV/PO, LLC, Seattle, Washington, USA.
Terry O'ReillyCelerion, Tempe, Arizona, USA.
J Greg SlatterKartos Therapeutics, Inc, Redwood City, CA and, Bellevue, Washington, USA.
Heron Therapeutics (United States) · USIntegra LifeSciences (United States) · USAptevo Therapeutics (United states) · USCelerion (United States) · USCertara (United States) · USWashington Poison Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This single 60-mg dose, 4-period crossover study assessed the effect of food and formulation change on navtemadlin (KRT-232) pharmacokinetics (PK) and macrophage inhibitory cytokine-1 (MIC-1) pharmacodynamics. Healthy subjects (N = 30) were randomized to 3 treatment sequences, A: new tablet, fasted (reference, dosed twice); B: new tablet, 30 minutes after a high-fat meal (test 1); C: old tablet, fasted (test 2). PK/pharmacodynamic parameters were measured over 0 to 96 hours. Adverse events were mild without any discontinuations. No serious adverse events or deaths occurred. In treatment A, navtemadlin mean (coefficient of variation) maximum concentration (C

Indexed as

Food-Drug InteractionsProto-Oncogene Proteins c-mdm2Administration, OralButanesCross-Over StudiesCytokinesHealthy VolunteersHumansMacrophagesPiperidinesSulfhydryl CompoundsTabletsButanesCytokinesnavtemadlin; 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acidPiperidinesProto-Oncogene Proteins c-mdm2Sulfhydryl CompoundsTabletsfood effectGDF15KRT-232MDM2 inhibitorMIC-1navtemadlinpharmacodynamicspharmacokinetics

Identifiers

PMID35172043
PMCPMC9306949
OpenAlexW4213217342

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.