ArticleClinical pharmacokinetics2021
Population Pharmacokinetics of Brigatinib in Healthy Volunteers and Patients With Cancer.
Article in Clinical pharmacokinetics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled 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.
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
19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.
- Pooled it
- Pooled it
- A Phase 1 Study to Assess the Relative Bioavailability of Brigatinib Administered as an Oral Solution Versus an Immediate-Release Tablet in Healthy Adults.Clinical pharmacology in drug development · 2026Trial
- Population pharmacokinetics of mobocertinib in healthy volunteers and patients with non-small cell lung cancer.CPT: pharmacometrics & systems pharmacology · 2022Trial
- Population Pharmacokinetics of TAK-931, a Cell Division Cycle 7 Kinase Inhibitor, in Patients With Advanced Solid Tumors.Journal of clinical pharmacology · 2022Trial
- Brigatinib Dose Rationale in Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer: Exposure-Response Analyses of Pivotal ALTA Study.CPT: pharmacometrics & systems pharmacology · 2020Trial
- Therapeutic Drug Monitoring and Model-Informed Precision Dosing of Oral TKIs and PARP Inhibitors: A Practical Framework for Clinical Implementation.Clinical pharmacokinetics · 2026Review
- A Review on EGFR-Tyrosine Kinase Inhibitors and their Resistance Mechanisms.Current pharmaceutical design · 2026Review
- Population pharmacokinetics of iruplinalkib in healthy volunteers and patients with solid tumors.Clinical and translational science · 2025Article
- Pharmacokinetics, mass balance, and metabolism of [Cancer chemotherapy and pharmacology · 2024Article
- Clinical Pharmacology of Brigatinib: A Next-Generation Anaplastic Lymphoma Kinase Inhibitor.Clinical pharmacokinetics · 2023Review
- Brigatinib pharmacokinetics in patients with chronic hepatic impairment.Investigational new drugs · 2023Article
- Asia-Inclusive Clinical Research and Development Enabled by Translational Science and Quantitative Clinical Pharmacology: Toward a Culture That Challenges the Status Quo.Clinical pharmacology and therapeutics · 2023Article
- Pharmacometric analyses and clinical evidence for brigatinib dosing in anaplastic lymphoma kinase-positive non-small cell lung cancer.British journal of clinical pharmacology · 2022Article
- Predictiveness of the Human-CYP3A4-Transgenic Mouse Model (Cyp3aXAV) for Human Drug Exposure of CYP3A4-Metabolized Drugs.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Population pharmacokinetic and exposure-response analyses from ALTA-1L: Model-based analyses supporting the brigatinib dose in ALK-positive NSCLC.Clinical and translational science · 2022Article
- Pharmacokinetically-guided dosing to improve the efficacy of brigatinib in non-small cell lung cancer patients.British journal of clinical pharmacology · 2022Article
- Effect of severe renal impairment on the pharmacokinetics of brigatinib.Investigational new drugs · 2021Article
- A Novel Integrated Pharmacokinetic-Pharmacodynamic Model to Evaluate Combination Therapy and DetermineThe Journal of pharmacology and experimental therapeutics · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesBrigatinib is an oral tyrosine kinase inhibitor approved in multiple countries for the treatment of patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer who have progressed on or are intolerant to crizotinib. We report a population pharmacokinetic model-based analysis for brigatinib.
methodsPlasma concentration-time data were collected from 442 participants (105 healthy volunteers and 337 patients with cancer) who received single or multiple doses of oral brigatinib in one of five trials. Data were analyzed using non-linear mixed-effects modeling (NONMEM software version 7.3).
resultsBrigatinib plasma concentrations were best described by a three-compartment model with a transit compartment input (number of transit compartments = 2.35; mean transit time = 0.9 h). The final model included albumin as a covariate on apparent clearance. None of the additional covariates examined, including sex, age, race, body weight, mild or moderate renal impairment, total bilirubin, aspartate aminotransferase, and alanine aminotransferase, were found to meaningfully explain variability in apparent clearance, suggesting that no dose adjustment is required based on these covariates.
conclusionsResults from these population pharmacokinetic analyses informed the prescribing guidance for patients with mild or moderate renal impairment in the US Prescribing Information and the European Summary of Product Characteristics for brigatinib.
Indexed as
Identifiers
What OpenQuestion holds
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.