Trial reportBritish journal of clinical pharmacology2022
Pharmacokinetics, pharmacodynamics and safety of BAY 2433334, a novel activated factor XI inhibitor, in healthy volunteers: A randomized phase 1 multiple-dose study.
Trial report in British journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Who cites it
31 citing papers in PubMed, 1 synthesis or guideline pooled it, 65 citations in OpenAlex.
- Emerging trends in anticoagulation therapy: a bibliometric analysis of DOACs and endogenous coagulation pathway inhibitors.Naunyn-Schmiedeberg's archives of pharmacology · 2025Pooled it
- Effect of Age, Sex, Renal Impairment and Hepatic Impairment on the Safety, Pharmacokinetics and Pharmacodynamics of Asundexian.Clinical pharmacokinetics · 2024Trial
- Pharmacokinetics, pharmacodynamics, and safety of asundexian in healthy Chinese and Japanese volunteers, and comparison with Caucasian data.Clinical and translational science · 2024Trial
- Pharmacokinetics, pharmacodynamics and safety of BAY 2433334, a novel activated factor XI inhibitor, in healthy volunteers: A randomized phase 1 multiple-dose study.British journal of clinical pharmacology · 2022Trial
- Translational Development of Oral FXIa Inhibitors: A Systematic Review of Molecular Design, Pharmacology, and Indication-Specific Clinical Evidence.Pharmaceuticals (Basel, Switzerland) · 2026Review
- An Overview of Anticoagulant Drugs Pharmacology, Therapeutic Approaches, Limitations and Perspectives.Pharmaceutics · 2026Review
- Asundexian: a systematic review of safety, efficacy, and pharmacological insights in thrombosis.Thrombosis journal · 2025Review
- Population Pharmacokinetics of Asundexian in People at Risk for Thromboembolic/Cardiovascular Events.CPT: pharmacometrics & systems pharmacology · 2025Article
- Factor XI inhibitors for the prevention and treatment of venous and arterial thromboembolism.Nature reviews. Cardiology · 2025Review
- Impact of asundexian on a panel of coagulation assays.Research and practice in thrombosis and haemostasis · 2025Article
- Management of bleeding and invasive procedures in patients treated with anti-factor XI(a) anticoagulants: proposals from the French Working Group on Perioperative Haemostasis and French Society of Thrombosis and Haemostasis.Research and practice in thrombosis and haemostasis · 2025Article
- Asundexian: A Friend or a Foe for Atrial Fibrillation?Clinical Medicine Insights. Cardiology · 2025Article
- Factor XI and Atrial Fibrillation: A Mismatched Pairing?European cardiology · 2025Article
- Study on Preparation Process of Anticoagulant BAY2433334.Molecules (Basel, Switzerland) · 2024Article
- Factor XI: structure, function and therapeutic inhibition.Journal of thrombosis and thrombolysis · 2024Review
- The third-generation anticoagulants: factors XI, XII, and XIII inhibitors.The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology · 2024Review
- Novel horizons in anticoagulation: the emerging role of factor XI inhibitors across different settings.Haematologica · 2024Review
- Laboratory Evaluation of Interferences Associated with Factor XIa Inhibitors Asundexian and Milvexian in Routine Coagulation Assays.Diagnostics (Basel, Switzerland) · 2024Article
- Review
- Drug-Drug Interactions of FXI Inhibitors: Clinical Relevance.Hematology reports · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo evaluate BAY 2433334, an oral activated factor XI (FXIa) inhibitor, in volunteers.
methodsPhase 1 study of healthy men at a German centre. Part A: randomized, single-blind, multiple dose-escalation study of BAY 2433334 (25/50/100 mg once daily [OD]) vs. placebo. Part B: similar design to Part A; evaluated BAY 2433334 25 mg twice daily. Part C: nonrandomized, open-label study; evaluated potential interactions between BAY 2433334 (25/75 mg OD) and midazolam (7.5 mg), a CYP3A4 index substrate. Primary variables: treatment-emergent adverse events (TEAEs; Parts A and B); area under the plasma concentration-time curve (AUC) and maximum plasma concentration of midazolam and α-hydroxymidazolam (Part C). STUDY PERIOD: 18 days plus follow-up visit.
resultsParts A and B: 36 participants randomized to BAY 2433334; 12 to placebo. Part C: 48 participants assigned to BAY 2433334 plus midazolam. BAY 2433334 was well tolerated in all study parts. AUC and maximum plasma concentration of BAY 2433334 in plasma appeared dose proportional over 25-100 mg OD, with low-to-moderate variability in pharmacokinetic parameters. Multiple dosing caused minor-to-moderate accumulation and a mean terminal half-life (15.8-17.8 h) supporting once-daily dosing. Dose-dependent FXIa activity inhibition and activated partial thromboplastin time prolongation were observed. BAY 2433334 appeared to have a minor effect on AUC for midazolam (ratio [90% confidence interval]: 1.1736 [1.0963-1.2564]) and α-hydroxymidazolam (0.9864 [0.9169-1.0612]) only for BAY 2433334 75 mg OD on day 10.
conclusionMultiple dosing of BAY 2433334 in healthy volunteers was well tolerated, with a predictable pharmacokinetic/pharmacodynamic profile and no clinically relevant CYP3A4 induction or inhibition.
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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.