Evidence map›Paper›PMID 36978270›Full record

Trial reportClinical and translational science2023

Relative bioavailability and food effect study of an oral suspension of alectinib in healthy volunteers using venipuncture and capillary microsampling.

Stephanie N Liu, Priya Agarwal, Katja Heinig, Asim Datye, Carolina Sturm-Pellanda, Andrea Crugnola, Marc Arca, Dale Miles

Open access · goldAbstract readRandomized 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. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.6field-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.

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

4 citing papers in PubMed, 2 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

8 authors at 2 institutions in 2 countries.

Stephanie N LiuGenentech Inc., South San Francisco, California, USA.
Priya AgarwalGenentech Inc., South San Francisco, California, USA.
Katja HeinigF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Asim DatyeF. Hoffmann-La Roche, Mississauga, Ontario, Canada.
Carolina Sturm-PellandaF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Andrea CrugnolaF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Marc ArcaF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Dale MilesGenentech Inc., South San Francisco, California, USA.
Roche (Switzerland) · CHRoche (Canada) · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Alectinib, approved as 150 mg capsules for the treatment of adults with advanced ALK-positive non-small cell lung cancer, is being assessed in children with ALK-positive solid and central nervous system tumors. An ad hoc pediatric-friendly suspension of alectinib, prepared from capsule contents, is under investigation as an alternative formulation for children who cannot swallow capsules. This randomized, crossover, relative bioavailability, and food effect study evaluated alectinib administered as an oral suspension versus capsule formulation following conventional venipuncture and capillary microsampling. A total of 28 healthy adult subjects received a 600 mg single dose of alectinib in two groups: fasted (n = 14) and mixed fed (n = 14; seven receiving high-fat meal and seven receiving low-fat meal). Combined alectinib + M4 (active metabolite) exposure was higher for suspension versus capsule, with geometric mean ratio (GMR) of 2.6 for area under the concentration-time curve extrapolated to infinity (AUC

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAdministration, OralAdultBiological AvailabilityCapsulesCarbazolesChildHealthy VolunteersHumansPhlebotomyPiperidinesReceptor Protein-Tyrosine KinasesalectinibCapsulesCarbazolesPiperidinesReceptor Protein-Tyrosine Kinases

Identifiers

PMID36978270
PMCPMC10264912
OpenAlexW4361201958

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.