Evidence map›Paper›PMID 37905356›Full record

Trial reportClinical and translational science2023

Phase I crossover study of DNA-protein kinase inhibitor peposertib in healthy volunteers: Effect of food and pharmacokinetics of an oral suspension.

Andreas Becker, Axel Krebs-Brown, Claudia Vetter, Tanja Reuter, Almudena Rodriguez-Gutierrez, Xiaoli You, Michael Lissy

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04702698 (Phase I, Open-Label, Randomized, Single-Dose Study With Crossover Design to Investigate the Effect of Food on the PK of Peposertib Tablet Formulation and to Investigate the PK of Peposertib Administered as Oral Suspension of Disintegrated Tablets), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 32% 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.

NCT04702698 phase1completednot on this map

Phase I, Open-Label, Randomized, Single-Dose Study With Crossover Design to Investigate the Effect of Food on the PK of Peposertib Tablet Formulation and to Investigate the PK of Peposertib Administered as Oral Suspension of Disintegrated Tablets

TypeinterventionalSponsorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyRan2021 to 2021Enrolled12ConditionsHealthyArmsPeposertib
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. 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 3 institutions in 2 countries.

Andreas BeckerThe healthcare business of Merck KGaA, Darmstadt, Germany.ORCID 0000-0001-7424-2588
Axel Krebs-BrownThe healthcare business of Merck KGaA, Darmstadt, Germany.
Claudia VetterThe healthcare business of Merck KGaA, Darmstadt, Germany.
Tanja ReuterThe healthcare business of Merck KGaA, Darmstadt, Germany.
Almudena Rodriguez-GutierrezMerck, S.L.U., Madrid, Spain, an affiliate of Merck KGaA, Darmstadt, Germany.
Xiaoli YouEMD Serono, Billerica, MA, USA.
Michael LissyNUVISAN GmbH, Neu-Ulm, Germany.
Merck (Germany) · DENuvisan (Germany) · DEOno Pharmaceutical (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Peposertib is an orally administered inhibitor of DNA-dependent protein kinase. We evaluated the effect of food on its pharmacokinetics, and examined the pharmacokinetics of an oral suspension (OS) of disintegrated tablets, in a phase I, open-label, crossover three-period study (NCT04702698). Twelve healthy volunteers were randomized to one of six treatment sequences. They received a single dose of peposertib 100 mg as film-coated tablets under fasted or fed conditions ("tablet fasted" or "tablet fed") or as an OS under fasted conditions ("OS fasted"), with washout between treatments. Using healthy volunteers was possible because, despite its mechanism of action being suppression of DNA repair, peposertib has shown no genotoxic effect in animals. A mild food effect was observed with peposertib tablets. Fed-to-fasted ratios were: area under the curve from time 0 to time t (AUC

Indexed as

FastingAdministration, OralBiological AvailabilityCross-Over StudiesHealthy VolunteersHumansPyridazinesQuinazolinesTabletspeposertibPyridazinesQuinazolinesTablets

Identifiers

PMID37905356
PMCPMC10719468
OpenAlexW4388034767

What OpenQuestion holds

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LicenceCC BY-NC
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.