Evidence map›Paper›PMID 41793065›Full record

ArticleJournal of clinical pharmacology2026

Combined Oral Contraceptive Drug-Drug Interaction Study With Ganfeborole, a New Anti-Tuberculosis Agent.

Laura Iavarone, Silvia M Lavezzi, Antonio J Carcas, Tetyana Chaychenko, Raquel Gabarro-Carrion, Arturo Gómez López de Las Huertas, Stephanie Gresham, Alicia Marín-Candón, Sophie L Penman, Katie Rolfe and 4 more

Abstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical pharmacology, 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

14 authors.

Laura IavaroneParexel International, Milan, Italy.
Silvia M LavezziParexel International, Dublin, Ireland.
Antonio J CarcasClinical Pharmacology Department, La Paz University Hospital, IdiPAZ, and School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.
Tetyana ChaychenkoGSK, London, UK.
Raquel Gabarro-CarrionGSK, Tres Cantos, Spain.
Arturo Gómez López de Las HuertasClinical Pharmacology Department, La Paz University Hospital, IdiPAZ, and School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.
Stephanie GreshamGSK, Stevenage, UK.
Alicia Marín-CandónClinical Pharmacology Department, La Paz University Hospital, IdiPAZ, and School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.
Sophie L PenmanGSK, London, UK.ORCID https://orcid.org/0009-0004-0991-9643
Katie RolfeGSK, London, UK.
Simon TiberiGSK, London, UK.
David Barros-AguirreGSK, Tres Cantos, Spain.
Alberto M BorobiaClinical Pharmacology Department, La Paz University Hospital, IdiPAZ, and School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.
ERA4TB consortium

Funding

EFPIAEuropean Union's Horizon 2020 Research and Innovation ProgrammeGlobal Alliance for TB Drug Development Non-Profit OrganizationGSK EudraCT: 2023-507839-38-00GSK NCT06354257Innovative Medicines Initiative 2 Joint Undertaking 853989the Bill & Melinda Gates Foundationthe University of Dundee
6 · The paper itself

Abstract

New drugs are urgently needed to treat drug-resistant tuberculosis in combination regimens. Ganfeborole demonstrated bactericidal activity and good tolerability in clinical trials. In preclinical studies, ganfeborole showed embryofetal developmental effects, currently mandating highly effective non-user dependent contraception in women of childbearing potential. We conducted a Phase 1, open-label, single-center, fixed sequence, 1-way drug-drug interaction (DDI) study in 20 healthy women of non-childbearing potential aged 18-65 years. The primary objective was to assess ganfeborole's effect at steady-state (20 mg daily) on single dose pharmacokinetics of ethinyl estradiol [EE] 0.03 mg/levonorgestrel [LNG] 15 mg (Bayer). Endpoints were EE and LNG area under the plasma concentration-time curve extrapolated to infinity (AUC

Indexed as

Antitubercular AgentsBoron CompoundsContraceptives, Oral, CombinedEthinyl EstradiolLevonorgestrelAdolescentAdultArea Under CurveDrug CombinationsDrug InteractionsFemaleHumansMiddle AgedYoung AdultAntitubercular AgentsBoron CompoundsContraceptives, Oral, CombinedDrug CombinationsEthinyl Estradiolethinyl estradiol, levonorgestrel drug combinationLevonorgestreldrug–drug interactionethinyl estradiolganfeborolelevonorgestrelpharmacokineticstuberculosis

Identifiers

PMID41793065
PMCPMC12966810

What OpenQuestion holds

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Registered trials

None linked

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.