Evidence map›Paper›PMID 33822485›Full record

ArticleCPT: pharmacometrics & systems pharmacology2021

PBPK modeling to predict drug-drug interactions of ivosidenib as a perpetrator in cancer patients and qualification of the Simcyp platform for CYP3A4 induction.

Jayaprakasam Bolleddula, Alice Ke, Hua Yang, Chandra Prakash

Open access · goldAbstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.1field-weighted citation impact, top 10% 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

16 citing papers in PubMed, 39 citations in OpenAlex.

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  9. Hydrocodone, Oxycodone, and Morphine Metabolism and Drug-Drug Interactions.The Journal of pharmacology and experimental therapeutics · 2023
    Review
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  11. Novel Approaches to Characterize Individual Drug Metabolism and Advance Precision Medicine.Drug metabolism and disposition: the biological fate of chemicals · 2023
    Review
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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

4 authors at 2 institutions in 2 countries.

Jayaprakasam BolleddulaAgios Pharmaceuticals, Inc, Cambridge, Massachusetts, USA.
Alice KeSimcyp Ltd, Sheffield, UK.
Hua YangAgios Pharmaceuticals, Inc, Cambridge, Massachusetts, USA.
Chandra PrakashAgios Pharmaceuticals, Inc, Cambridge, Massachusetts, USA.
Agios Pharmaceuticals (United States) · USSimcyp (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ivosidenib is a potent, targeted, orally active, small-molecule inhibitor of mutant isocitrate dehydrogenase 1 (IDH1) that has been approved in the United States for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are greater than or equal to 75 years of age or ineligible for intensive chemotherapy, and those with relapsed or refractory AML, with a susceptible IDH1 mutation. Ivosidenib is an inducer of the CYP2B6, CYP2C8, CYP2C9, and CYP3A4 and an inhibitor of P-glycoprotein (P-gp), organic anion transporting polypeptide-1B1/1B3 (OATP1B1/1B3), and organic anion transporter-3 (OAT3) in vitro. A physiologically-based pharmacokinetic (PK) model was developed to predict drug-drug interactions (DDIs) of ivosidenib in patients with AML. The in vivo CYP3A4 induction effect of ivosidenib was quantified using 4β-hydroxycholesterol and was subsequently verified with the PK data from an ivosidenib and venetoclax combination study. The verified model was prospectively applied to assess the effect of multiple doses of ivosidenib on a sensitive CYP3A4 substrate, midazolam. The simulated midazolam geometric mean area under the curve (AUC) and maximum plasma concentration (C

Indexed as

Models, BiologicalAntineoplastic AgentsBridged Bicyclo Compounds, HeterocyclicCaco-2 CellsCytochrome P-450 CYP3ACytochrome P-450 Enzyme InducersDrug InteractionsFemaleGlycineHEK293 CellsHumansLeukemia, Myeloid, AcuteMembrane Transport ProteinsMidazolamPyridinesSulfonamidesAntineoplastic AgentsBridged Bicyclo Compounds, HeterocyclicCYP3A4 protein, humanCytochrome P-450 CYP3ACytochrome P-450 Enzyme InducersGlycineivosidenibMembrane Transport ProteinsMidazolamPyridinesSulfonamidesvenetoclax

Identifiers

PMID33822485
PMCPMC8213421
OpenAlexW3152382005

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.