Evidence map›Paper›PMID 31011758›Full record

Trial reportEuropean journal of clinical pharmacology2019

Effect of itraconazole, food, and ethnic origin on the pharmacokinetics of ivosidenib in healthy subjects.

David Dai, Hua Yang, Salah Nabhan, Hua Liu, Denice Hickman, Guowen Liu, Jeffrey Zacher, Apinya Vutikullird, Chandra Prakash, Samuel Agresta and 2 more

3 registry-linked trialsAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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.

NCT02579707 phase1completednot on this map

A Phase 1, Open-Label, Randomized, 2-Period Crossover Study To Evaluate The Effect Of Food On AG-120 Pharmacokinetics Following Single Oral Dose Administration To Healthy Subjects

TypeinterventionalSponsorAgios Pharmaceuticals, Inc.Ran2015 to 2016Enrolled36ConditionsHealthyArmsAG120
NCT02831972 phase1completednot on this map

An Open-Label, 2-Period, Fixed Sequence Study to Determine the Effect of Multiple Oral Doses of Itraconazole on the Single Dose Pharmacokinetics of AG 120 in Healthy Adult Subjects

TypeinterventionalSponsorAgios Pharmaceuticals, Inc.Ran2016 to 2016Enrolled22ConditionsHealthyArmsAG120, Itraconazole
NCT03071770 phase1completednot on this map

A Phase 1, Single-Dose, Open-Label Trial to Evaluate the Pharmacokinetics and Safety of AG-120 in Healthy Male Japanese Subjects Relative to Healthy Male Caucasian Subjects

TypeinterventionalSponsorAgios Pharmaceuticals, Inc.Ran2017 to 2017Enrolled60ConditionsHealthyArmsivosidenib (AG-120)
3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. 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

12 authors.

David DaiAgios Pharmaceuticals, Inc., 88 Sidney Street, Cambridge, MA, 02139, USA.
Hua YangAgios Pharmaceuticals, Inc., 88 Sidney Street, Cambridge, MA, 02139, USA.
Salah NabhanAgios Pharmaceuticals, Inc., 88 Sidney Street, Cambridge, MA, 02139, USA.
Hua LiuAgios Pharmaceuticals, Inc., 88 Sidney Street, Cambridge, MA, 02139, USA.
Denice HickmanAgios Pharmaceuticals, Inc., 88 Sidney Street, Cambridge, MA, 02139, USA.
Guowen LiuAgios Pharmaceuticals, Inc., 88 Sidney Street, Cambridge, MA, 02139, USA.
Jeffrey ZacherCelerion, Tempe, AZ, USA.
Apinya VutikullirdWCCT Global, Cypress, CA, USA.
Chandra PrakashAgios Pharmaceuticals, Inc., 88 Sidney Street, Cambridge, MA, 02139, USA.
Samuel AgrestaAgios Pharmaceuticals, Inc., 88 Sidney Street, Cambridge, MA, 02139, USA.
Chris BowdenAgios Pharmaceuticals, Inc., 88 Sidney Street, Cambridge, MA, 02139, USA.
Bin FanAgios Pharmaceuticals, Inc., 88 Sidney Street, Cambridge, MA, 02139, USA. bin.fan@agios.com.

Funding

Agios Pharmaceuticals, Inc. n/a
6 · The paper itself

Abstract

purposeTo assess the effect of ethnicity, food, and itraconazole (strong CYP3A4 inhibitor) on the pharmacokinetics of ivosidenib after single oral doses in healthy subjects.

methodsThree phase 1 open-label studies were performed. Study 1: Japanese and Caucasian subjects received single doses of 250, 500, or 1000 mg ivosidenib (NCT03071770). Part 1 of study 2 (a two-period crossover study): subjects received 500 mg ivosidenib after either an overnight fast or a high-fat meal. Subjects received 1000 mg ivosidenib after an overnight fast in the single period of part 2 (NCT02579707). Study 3: in period 1, subjects received 250 mg ivosidenib; then, in period 2, subjects received oral itraconazole (200 mg once daily) on days 1-18, plus 250 mg ivosidenib on day 5 (NCT02831972).

resultsIvosidenib was well tolerated in all three studies. Study 1: pharmacokinetic profiles were generally comparable, although AUC and C

conclusionsNo ivosidenib dose adjustment is deemed necessary for Japanese subjects. High-fat meals should be avoided when ivosidenib is taken with food. When co-administered with strong CYP3A4 inhibitors, monitoring for QT interval prolongation (a previously defined adverse event of interest) is recommended and an ivosidenib dose interruption or reduction may be considered. CLINICALTRIALS.GOV : NCT03071770, NCT02579707, and NCT02831972.

Indexed as

Administration, OralAdultAntineoplastic AgentsArea Under CurveAsian PeopleCross-Over StudiesCytochrome P-450 CYP3A InhibitorsDose-Response Relationship, DrugDrug InteractionsFemaleFood-Drug InteractionsGlycineHealthy VolunteersHumansItraconazoleLeukemia, Myeloid, AcuteAntineoplastic AgentsCytochrome P-450 CYP3A InhibitorsGlycineItraconazoleivosidenibPyridinesCYP3A4 inhibitorsDrug interactionFood effectIsocitrate dehydrogenase 1 inhibitorIvosidenibPharmacokinetics

Identifiers

PMID31011758

What OpenQuestion holds

Textmetadata
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.