Evidence map›Paper›PMID 38757982›Full record

ArticleAntimicrobial agents and chemotherapy2024

Phase 1 drug-drug interaction study to assess the effect of CYP3A4 inhibition and pan-CYP induction on the pharmacokinetics and safety of fosmanogepix in healthy participants.

Michael R Hodges, Sjoerd van Marle, William G Kramer, Eric Ople, Margaret Tawadrous, Abhijeet Jakate

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04166669 (A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study of APX001 to Evaluate the Effects of CYP3A4 Inhibition and Pan-CYP Induction in Two Parallel Groups of Healthy Male and Female Subjects), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

NCT04166669 phase1completednot on this map

A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study of APX001 to Evaluate the Effects of CYP3A4 Inhibition and Pan-CYP Induction in Two Parallel Groups of Healthy Male and Female Subjects

TypeinterventionalSponsorBasilea PharmaceuticaRan2019 to 2020Enrolled36ConditionsFungal InfectionArmsAPX001, Itraconazole, Rifampin
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. New Perspectives on Antimicrobial Agents: Fosmanogepix.Antimicrobial agents and chemotherapy · 2026
    Review
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  4. 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

6 authors.

Michael R HodgesIndependent / Former Amplyx and Pfizer, San Diego, California, USA.
Sjoerd van MarleICON, Groningen, the Netherlands.
William G KramerKramer Consulting LLC, North Potomac, Maryland, USA.
Eric OpleIndependent / Former Amplyx Pharmaceuticals, Inc., San Diego, California, USA.
Margaret TawadrousPfizer Inc., Peapack, New Jersey, USA.ORCID 0000-0002-6815-2647
Abhijeet JakatePfizer Inc., Peapack, New Jersey, USA.ORCID 0009-0000-2196-5782

Funding

Amplyx (Amplyx Pharmaceuticals)
6 · The paper itself

Abstract

Immunocompromised patients are susceptible to fungal infections, and drug-drug interactions with antifungals may occur due to concomitant medications. Fosmanogepix [FMGX; active moiety manogepix (MGX)] targets glycosylphosphatidylinositol-anchored mannoprotein synthesis and maturation, essential for fungal virulence. This phase 1, fixed-sequence study in healthy participants evaluated the effect of strong CYP3A4 inhibitor itraconazole [Cohort 1 ( CLINICAL TRIALS: This study is registered with ClinicalTrials.gov as NCT04166669 and with EudraCT as number 2019-003586-17.

Indexed as

Antifungal AgentsCytochrome P-450 CYP3ACytochrome P-450 CYP3A InhibitorsDrug InteractionsHealthy VolunteersItraconazoleRifampinAdministration, OralAdultArea Under CurveCytochrome P-450 CYP3A InducersFemaleHumansMaleMiddle AgedYoung AdultAntifungal AgentsCYP3A4 protein, humanCytochrome P-450 CYP3ACytochrome P-450 CYP3A InducersCytochrome P-450 CYP3A InhibitorsItraconazoleRifampinCYP450FMGX/APX001itraconazoleMGX/APX001Arifampin

Identifiers

PMID38757982
PMCPMC11620482

What OpenQuestion holds

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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.