Evidence map›Paper›PMID 34080309›Full record

ArticleClinical and translational science2021

Model-based assessments of CYP3A-mediated drug-drug interaction risk of milademetan.

Ying Hong, Tomoko Ishizuka, Akiko Watanabe, Masaya Tachibana, Mark Lee, Hitoshi Ishizuka, Frank LaCreta, Malaz Abutarif

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Clinical and translational science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03614455 (An Open-label, Randomized, 2-period, 2-sequence Study to Evaluate the Single-dose Pharmacokinetics of Milademetan When Administered Alone or Concomitantly With Itraconazole or Posaconazole in Healthy Subjects), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.6field-weighted citation impact, top 29% 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.

NCT03614455 early_phase1completednot on this map

An Open-label, Randomized, 2-period, 2-sequence Study to Evaluate the Single-dose Pharmacokinetics of Milademetan When Administered Alone or Concomitantly With Itraconazole or Posaconazole in Healthy Subjects

TypeinterventionalSponsorDaiichi SankyoRan2018 to 2018Enrolled36ConditionsPharmacokineticsArmsMilademetan, Itraconazole, Posaconazole
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
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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

8 authors at 2 institutions in 3 countries.

Ying HongQuantitative Clinical Pharmacology, Daiichi Sankyo, Inc, Basking Ridge, New Jersey, USA.
Tomoko IshizukaDrug Metabolism and Pharmacokinetics Research Laboratories, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Akiko WatanabeQuantitative Clinical Pharmacology, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Masaya TachibanaQuantitative Clinical Pharmacology, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Mark LeeQuantitative Clinical Pharmacology, Daiichi Sankyo, Inc, Basking Ridge, New Jersey, USA.
Hitoshi IshizukaQuantitative Clinical Pharmacology, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Frank LaCretaQuantitative Clinical Pharmacology, Daiichi Sankyo, Inc, Basking Ridge, New Jersey, USA.
Malaz AbutarifQuantitative Clinical Pharmacology, Daiichi Sankyo, Inc, Basking Ridge, New Jersey, USA.
Daiichi-Sankyo (Japan) · JPDaiichi Sankyo (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Milademetan is a small-molecule inhibitor of murine double minute 2 (MDM2) that is in clinical development for advanced solid tumors and hematological cancers, including liposarcoma and acute myeloid leukemia. Milademetan is a CYP3A and P-glycoprotein substrate and moderate CYP3A inhibitor. The current study aims to understand the drug-drug interaction (DDI) risk of milademetan as a CYP3A substrate during its early clinical development. A clinical DDI study of milademetan (NCT03614455) showed that concomitant administration of single-dose milademetan with the strong CYP3A inhibitor itraconazole or posaconazole increased milademetan mean area under the curve from zero to infinity (AUC

Indexed as

Drug InteractionsCytochrome P-450 CYP3A InhibitorsHumansIndolesItraconazolePyridinesPyrrolidinesRisk AssessmentTriazolesCytochrome P-450 CYP3A InhibitorsIndolesItraconazolemilademetanposaconazolePyridinesPyrrolidinesTriazoles

Identifiers

PMID34080309
PMCPMC8604211
OpenAlexW3164290642

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.