Evidence map›Paper›PMID 41757749›Full record

ArticleClinical and translational science2026

Evaluation of Drug-Drug Interaction Potential Between the Oral Antibiotic Zoliflodacin and the CYP3A4 Inhibitor Itraconazole: A Phase 1 Study in Healthy Participants.

Alison Luckey, Kajal B Larson, Noha Rayad, Markus Heep, Sophie Delhomme, Gabrielle Kornmann, John P Mueller, John P O'Donnell, Seamus O'Brien, Rainard Fuhr and 1 more

Abstract readClinical Trial, Phase I
In one paragraph

Article in Clinical and translational science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

11 authors.

Alison LuckeyGlobal Antibiotic Research & Development Partnership (GARDP), Geneva, Switzerland.ORCID 0000-0002-5831-8914
Kajal B LarsonInnoviva Specialty Therapeutics, Inc., Waltham, Massachusetts, USA.
Noha RayadParexel International (MA) Corporation, Mississauga, Ontario, Canada.ORCID 0000-0002-6413-6359
Markus HeepGlobal Antibiotic Research & Development Partnership (GARDP), Geneva, Switzerland.
Sophie DelhommeDrugs for Neglected Diseases Initiative (DNDi), Geneva, Switzerland.
Gabrielle KornmannGlobal Antibiotic Research & Development Partnership (GARDP), Geneva, Switzerland.ORCID 0000-0003-2955-9265
John P MuellerInnoviva Specialty Therapeutics, Inc., Waltham, Massachusetts, USA.ORCID 0000-0001-9368-4015
John P O'DonnellInnoviva Specialty Therapeutics, Inc., Waltham, Massachusetts, USA.ORCID 0000-0001-5502-8738
Seamus O'BrienGlobal Antibiotic Research & Development Partnership (GARDP), Geneva, Switzerland.ORCID 0009-0008-3678-5715
Rainard FuhrParexel International GmbH, Berlin, Germany.
Jean-Yves GillonDrugs for Neglected Diseases Initiative (DNDi), Geneva, Switzerland.ORCID 0000-0003-1467-0403

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Zoliflodacin is a first-in-class oral spiropyrimidinetrione antibiotic being developed for patients with uncomplicated gonorrhea, including those infected with multidrug-resistant strains. Because zoliflodacin is metabolized by cytochrome P450 3A4 (CYP3A4), concomitant administration with a CYP3A inhibitor has the potential to increase zoliflodacin plasma exposure. The aim of this phase 1 drug-drug interaction (DDI) study was to assess the effect of the strong CYP3A4 inhibitor itraconazole on the pharmacokinetics (PK) and safety of a 3 g single oral dose of zoliflodacin. This was an open label, 2-period, 2-treatment, fixed sequence crossover DDI study. Eighteen eligible adult participants were dosed and completed the study. When zoliflodacin was co-administered with itraconazole at steady state, as determined by itraconazole trough plasma concentrations, zoliflodacin exposure increased as measured by peak concentration (C

Indexed as

Anti-Bacterial AgentsBiphenyl CompoundsCytochrome P-450 CYP3A InhibitorsItraconazoleAdministration, OralAdolescentAdultArea Under CurveBarbituratesCross-Over StudiesCytochrome P-450 CYP3ADrug InteractionsFemaleHealthy VolunteersHumansIsoxazolesAnti-Bacterial AgentsBarbituratesBiphenyl CompoundsCYP3A4 protein, humanCytochrome P-450 CYP3ACytochrome P-450 CYP3A InhibitorsIsoxazolesItraconazoleMorpholinesOxazolidinonesSpiro Compoundszoliflodacinantibioticsdrug–drug interactionsmetabolismpharmacokineticssafety

Identifiers

PMID41757749
PMCPMC12947315

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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.