ArticleCardiology and therapy2022
Effects of Itraconazole and Diltiazem on the Pharmacokinetics and Pharmacodynamics of Milvexian, A Factor XIa Inhibitor.
Article in Cardiology and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02807909 (An Open-Label Single-Sequence Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Single-Dose Pharmacokinetics of BMS-986177 in Healthy Subjects), which is not on this map. Cited by 13 papers.
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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.
An Open-Label Single-Sequence Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Single-Dose Pharmacokinetics of BMS-986177 in Healthy Subjects
Who cites it
13 citing papers in PubMed, 22 citations in OpenAlex.
- A Thorough QT Study to Assess the Effects of Milvexian on Cardiac Repolarization in Healthy Participants.Clinical pharmacology in drug development · 2026Trial
- Safety, tolerability, pharmacokinetics and pharmacodynamics of milvexian with aspirin and/or clopidogrel in healthy participants.Scientific reports · 2024Trial
- Factor XI(a) Inhibition in Secondary Stroke Prevention: On the Cusp of a New Anticoagulation Paradigm.ACS pharmacology & translational science · 2026Article
- Translational Development of Oral FXIa Inhibitors: A Systematic Review of Molecular Design, Pharmacology, and Indication-Specific Clinical Evidence.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Factor XI Inhibition for Ischemic Stroke Secondary Prevention: Pharmacology, Clinical Evidence, and Future Directions.Journal of clinical pharmacology · 2026Review
- Factor XI inhibitors are the novel promising anticoagulants in the treatment of age related thrombotic disease.Frontiers in cardiovascular medicine · 2025Review
- Review
- Drug-Drug Interactions of FXI Inhibitors: Clinical Relevance.Hematology reports · 2024Review
- Factor XI and XIa inhibition: a new approach to anticoagulant therapy.The British journal of cardiology · 2024Article
- Determination of the Potential Clinical Benefits of Small Molecule Factor XIa Inhibitors in Arterial Thrombosis.ACS pharmacology & translational science · 2023Review
- Factor XIa Inhibitors as a Novel Anticoagulation Target: Recent Clinical Research Advances.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Rationale and design of the AXIOMATIC-SSP phase II trial: Antithrombotic treatment with factor XIa inhibition to Optimize Management of Acute Thromboembolic events for Secondary Stroke Prevention.Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association · 2022Article
- Factor XI, a potential target for anticoagulation therapy for venous thromboembolism.Frontiers in cardiovascular medicine · 2022Review
Corrections and comments
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Authors and funding
9 authors at 1 institution in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionModulation of Factor XIa (FXIa) may provide a novel mechanism for systemic anticoagulation with the potential to improve the risk-benefit profile observed with existing anticoagulants through greater efficacy or a safer bleeding profile. This study assessed the effects of co-administration with strong and moderate CYP3A inhibitors itraconazole and diltiazem, respectively, on the pharmacokinetic and pharmacodynamic properties of milvexian, a Factor XIa inhibitor.
methodsThis was an open-label, non-randomized, two-period crossover study in healthy participants. In period 1, participants received a single oral dose of milvexian (30 mg) on day 1, followed by a washout on days 2 and 3. In period 2, participants received multiple oral doses of itraconazole (200 mg) or diltiazem (240 mg) with a single dose of milvexian.
resultsA total of 28 participants entered the treatment period. Following itraconazole co-administration, milvexian exposure was increased; AUC
conclusionsA moderate increase in milvexian exposure was observed following co-administration of itraconazole while a minimal increase was seen with diltiazem, consistent with the involvement of CYP3A metabolism and P-glycoprotein in drug absorption/elimination. Milvexian was generally safe and well tolerated in healthy participants.
trial registrationThe study was registered with ClinicalTrials.gov (NCT02807909; submitted June 17, 2016).
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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.