Evidence map›Paper›PMID 40346993›Full record

Trial reportClinical pharmacology in drug development2025

Effect of Cytochrome P450 3A Inhibition and Induction by Itraconazole and Rifampin on Tazemetostat Pharmacokinetics in Patients With Advanced Malignancies.

Yingxue Chen, Renli Teng, Attila Szanto, Apoorva Kapopara, Rajat Bannerji, Julien Ogier, Devalingam Mahalingam

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical pharmacology in drug development, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04537715 (A Phase I, Open-label Multi-dose Two-part Study to Characterize the Effects of a Strong CYP3A4 Inhibitor and a Strong CYP3A4 Inducer on the Steady-State Pharmacokinetics of Tazemetostat), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT04537715 phase1completednot on this map

A Phase I, Open-label Multi-dose Two-part Study to Characterize the Effects of a Strong CYP3A4 Inhibitor and a Strong CYP3A4 Inducer on the Steady-State Pharmacokinetics of Tazemetostat (EPZ-6438) in Subjects With Advanced Malignancies

TypeinterventionalSponsorEpizyme, Inc.Ran2020 to 2023Enrolled42ConditionsAll Malignancies, Advanced Malignancies, Hematologic Malignancy, Solid TumorArmsTazemetostat, Itraconazole, Rifampin
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Drug-Drug Interactions in Recently Approved Antibacterials: A Mini Review.European journal of drug metabolism and pharmacokinetics · 2026
    Review
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.

Yingxue ChenIPSEN BIOSCIENCE INC, Cambridge, MA, USA.
Renli TengCareCeutics, LLC, Berwyn, PA, USA.
Attila SzantoIPSEN BIOSCIENCE INC, Cambridge, MA, USA.
Apoorva KapoparaIPSEN BIOSCIENCE INC, Cambridge, MA, USA.
Rajat BannerjiIPSEN BIOSCIENCE INC, Cambridge, MA, USA.
Julien OgierIpsen Innovation, Les Ulis, France.
Devalingam MahalingamRobert H. Lurie Comprehensive Cancer Center, Chicago, IL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study (NCT04537715) investigated itraconazole (strong cytochrome P450 [CYP] 3A inhibitor) and rifampin (strong CYP3A inducer) on tazemetostat pharmacokinetics. In Part 1, patients received tazemetostat 400 mg orally on Days 1, 15, and 36, and 400 mg twice daily on Days 3-14 and Days 21-35. Itraconazole 200 mg orally once daily was administered on Days 18-38. In Part 2, patients received tazemetostat 800 mg orally once daily on Days 1, 15, and 24, and 800 mg twice daily on Days 3-14 and Days 17-23. Rifampin 600 mg orally once daily was administered on Days 17-25. Twenty-one patients in each part completed had plasma concentrations quantified for pharmacokinetic assessments. Itraconazole coadministration resulted in higher tazemetostat exposures after single doses (Day 21/Day 1) and steady state (Day 36/Day 15). Compared with tazemetostat alone, itraconazole increased mean maximum plasma concentration (C

Indexed as

Cytochrome P-450 CYP3A InducersCytochrome P-450 CYP3A InhibitorsItraconazoleNeoplasmsRifampinAdultAgedArea Under CurveCytochrome P-450 CYP3ADrug InteractionsFemaleHumansMaleMiddle AgedCytochrome P-450 CYP3ACytochrome P-450 CYP3A InducersCytochrome P-450 CYP3A InhibitorsItraconazoleRifampinCYP3A inductionCYP3A inhibitiondrug‐drug interactionpharmacokineticstazemetostat

Identifiers

PMID40346993
PMCPMC12209990

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.