ArticleClinical drug investigation2017
Evaluation of the Pharmacokinetic Interaction between Venetoclax, a Selective BCL-2 Inhibitor, and Warfarin in Healthy Volunteers.
Article in Clinical drug investigation, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
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.
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Who cites it
22 citing papers in PubMed, 50 citations in OpenAlex.
- Semimechanistic Modeling to Guide Venetoclax Coadministration with Ritonavir and Digoxin.Clinical and translational science · 2020Trial
- Bayesian Population Model of the Pharmacokinetics of Venetoclax in Combination with Rituximab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Results from the Phase III MURANO Study.Clinical pharmacokinetics · 2019Trial
- Pharmacokinetics of the B-Cell Lymphoma 2 (Bcl-2) Inhibitor Venetoclax in Female Subjects with Systemic Lupus Erythematosus.Clinical pharmacokinetics · 2018Trial
- Therapeutic Drug Monitoring: A New Hope for Individualised Treatment with Venetoclax.Current drug targets · 2025Review
- Prediction of Drug-Drug Interactions for Highly Plasma Protein Bound Compounds.The AAPS journal · 2024Article
- Molecularly Imprinted Electrochemical Sensor for the Ultrasensitive and Selective Detection of Venetoclax.ACS omega · 2024Article
- Clinical pharmacokinetics and pharmacodynamics of venetoclax, a selective B-cell lymphoma-2 inhibitor.Clinical and translational science · 2024Review
- Therapeutic Monitoring of Orally Administered, Small-Molecule Anticancer Medications with Tumor-Specific Cellular Protein Targets in Peripheral Fluid Spaces-A Review.Pharmaceutics · 2023Review
- Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet.Clinical drug investigation · 2022Article
- Venetoclax penetrates in cerebrospinal fluid of an acute myeloid leukemia patient with leptomeningeal involvement.Cancer chemotherapy and pharmacology · 2022Article
- A microdosing framework for absolute bioavailability assessment of poorly soluble drugs: A case study on cold-labeled venetoclax, from chemistry to the clinic.Clinical and translational science · 2022Article
- Development and Characterization of Venetoclax Nanocrystals for Oral Bioavailability Enhancement.AAPS PharmSciTech · 2021Article
- Review
- Venetoclax in combination with cytarabine with or without idarubicin in children with relapsed or refractory acute myeloid leukaemia: a phase 1, dose-escalation study.The Lancet. Oncology · 2020Article
- Exposure-Response Analyses of the Effects of Venetoclax, a Selective BCL-2 Inhibitor, on B-Lymphocyte and Total Lymphocyte Counts in Women with Systemic Lupus Erythematosus.Clinical pharmacokinetics · 2020Article
- Clinical Pharmacokinetic and Pharmacodynamic Considerations in Treating Non-Hodgkin Lymphoma.Clinical pharmacokinetics · 2020Review
- Model-Informed Dosing of Venetoclax in Healthy Subjects: An Exposure-Response Analysis.Clinical and translational science · 2019Article
- Venetoclax: A Review in Relapsed/Refractory Chronic Lymphocytic Leukemia.Targeted oncology · 2019Review
- Pharmacokinetics of the BCL-2 Inhibitor Venetoclax in Subjects with Hepatic Impairment.Clinical pharmacokinetics · 2019Article
- Venetoclax penetrates in cerebrospinal fluid and may be effective in chronic lymphocytic leukemia with central nervous system involvement.Haematologica · 2019Article
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveVenetoclax is a selective, B-cell lymphoma-2 inhibitor that has demonstrated clinical efficacy in a variety of hematological malignancies. In vitro data indicated weak cytochrome P450 (CYP) 2C9 inhibition by venetoclax; however, it is not predicted to cause clinically relevant inhibition due to high plasma protein binding. A Phase 1 study was conducted in healthy volunteers to evaluate the effect of venetoclax on warfarin pharmacokinetics.
methodsSubjects received a single oral dose of 5 mg warfarin on day 1 of both periods 1 and 2, separated by a 14 days washout. On day 1 of period 2, subjects concomitantly received a single 400 mg oral dose of venetoclax. Blood samples for warfarin concentration determination were collected after each dose administration for up to 9 days.
resultsModest increases of 18 to 28% were observed in the maximum observed plasma concentration (C
conclusionsDue to the narrow therapeutic window of warfarin, it is recommended that the international normalized ratio (INR) be monitored closely in patients receiving venetoclax and warfarin. Since similar increases in exposure were observed for both enantiomers, even though CYP2C9 is only involved in the metabolism of the S-enantiomer, and the half-life of both enantiomers remained the same, the interaction does not appear to be mediated via CYP2C9.
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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.