Evidence map›Paper›PMID 28748626›Full record

ArticleCPT: pharmacometrics & systems pharmacology2017

Combining "Bottom-up" and "Top-down" Approaches to Assess the Impact of Food and Gastric pH on Pictilisib (GDC-0941) Pharmacokinetics.

Tong Lu, Grazyna Fraczkiewicz, Laurent Salphati, Nageshwar Budha, Gena Dalziel, Gillian S Smelick, Kari M Morrissey, John D Davis, Jin Y Jin, Joseph A Ware

Abstract readClinical Trial, Phase I
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2017. 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
–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

4 citing papers in PubMed.

  1. Article
  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

10 authors.

Tong LuDepartment of Clinical Pharmacology, Genentech Inc, South San Francisco, California, USA.
Grazyna FraczkiewiczSimulations Plus Inc, Lancaster, California, USA.
Laurent SalphatiDepartment of Drug Metabolism and Pharmacokinetics, Genentech Inc, South San Francisco, California, USA.
Nageshwar BudhaDepartment of Clinical Pharmacology, Genentech Inc, South San Francisco, California, USA.
Gena DalzielDepartment of Small Molecule Pharmaceutical Sciences, Genentech Inc, South San Francisco, California, USA.
Gillian S SmelickDepartment of Clinical Pharmacology, Genentech Inc, South San Francisco, California, USA.
Kari M MorrisseyDepartment of Clinical Pharmacology, Genentech Inc, South San Francisco, California, USA.
John D DavisDepartment of Clinical Pharmacology, Genentech Inc, South San Francisco, California, USA.
Jin Y JinDepartment of Clinical Pharmacology, Genentech Inc, South San Francisco, California, USA.
Joseph A WareDepartment of Clinical Pharmacology, Genentech Inc, South San Francisco, California, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pictilisib, a weakly basic compound, is an orally administered, potent, and selective pan-inhibitor of phosphatidylinositol 3-kinases for oncology indications. To investigate the significance of high-fat food and gastric pH on pictilisib pharmacokinetics (PK) and enable label recommendations, a dedicated clinical study was conducted in healthy volunteers, whereby both top-down (population PK, PopPK) and bottom-up (physiologically based PK, PBPK) approaches were applied to enhance confidence of recommendation and facilitate the clinical development through scenario simulations. The PopPK model identified food (for absorption rate constant (K

Indexed as

Administration, OralAnti-Ulcer AgentsBiological AvailabilityComputer SimulationCross-Over StudiesDiet, High-FatFemaleHealthy VolunteersHumansHydrogen-Ion ConcentrationIndazolesIntestinesMaleModels, BiologicalRabeprazoleRandom Allocation2-(1H-indazol-4-yl)-6-(4-methanesulfonylpiperazin-1-ylmethyl)-4-morpholin-4-ylthieno(3,2-d)pyrimidineAnti-Ulcer AgentsIndazolesRabeprazoleSulfonamides

Identifiers

PMID28748626
PMCPMC5702897

What OpenQuestion holds

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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.