ArticleCancer chemotherapy and pharmacology2025
Presence of drug-drug interactions between esomeprazole and an ALK tyrosine kinase inhibitor (Dirozalkib).
Article in Cancer chemotherapy and pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05586568 (A Drug-drug Interaction Study Evaluating the Pharmacokinetic Effects of Itraconazole or Rifampin or Esomeprazole on XZP-3621 Tablets in Healthy Subjects), which is not on this map. Not yet cited in PubMed.
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.
A Drug-drug Interaction Study Evaluating the Pharmacokinetic Effects of Itraconazole or Rifampin or Esomeprazole on XZP-3621 Tablets in Healthy Subjects
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
backgroundDirozalkib is a novel anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) with an intended indication for ALK-positive advanced non-small cell lung cancer (NSCLC). Given that the solubility of Dirozalkib is pH-dependent, this study was conducted to evaluate the effect of the acid-reducing agent, esomeprazole magnesium (EMZ-Mg) enteric-coated tablets, on the pharmacokinetics of Dirozalkib.
methodsIn this open-label, single center, two-treatment, single-sequence clinical trial, 24 healthy adults were enrolled. Participants received a single oral dose of 500 mg Dirozalkib on Day 1 and 16. Oral EMZ-Mg enteric-coated tablet (40 mg) were administered once daily from Days 11 to 16. Blood samples were collected, and plasma concentrations of Dirozalkib and its primary metabolite XZP-5089 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Pharmacokinetic parameters were derived via noncompartmental analysis, and safety was assessed throughout the study.
resultsAll 24 participants completed both treatment periods. Coadministration with EMZ-Mg enteric-coated tablet resulted in a reduction of the geometric mean maximum plasma concentration (Cmax), area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0 − t), and area under the curve from time zero to infinity (AUC0−∞) of Dirozalkib by about 27.0%, 12.0%, and 12.0%, respectively. The median time to maximum (Tmax) was prolonged from 3.0 h to 4.0 h (P = 0.005). The geometric mean ratios (GMRs) (coadministration/monotherapy) with their 90% confidence intervals (CIs) for Dirozalkib were: Cmax, 73.28% (64.18%-83.68%), AUC0 − t, 87.97% (81.36%-95.12%) and AUC0–∞: 88.12% (81.53%-95.24%). Similar effects were observed for the primary metabolite XZP-5089. Treatment-related adverse events (TRAEs) were reported by 20 participants (83.3%) following Dirozalkib monotherapy and 17 participants (70.8%) following coadministration, all of which were Grade 1 to 3 in severity.
conclusionThe co-administration of Dirozalkib and EMZ-Mg enteric-coated tablet slightly reduced the exposure of Dirozalkib and prolonged the peak time. CLINICAL
trial registrationThe study was registered at https://clinicaltrials.gov (NCT05586568).
Indexed as
Identifiers
41348226What 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.