Trial reportBritish journal of clinical pharmacology2025
Assessment of ethnic differences in pharmacokinetics and clinical responses of acalabrutinib between Chinese and White patients with B-cell malignancies.
Trial report in British journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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
2 citing papers in PubMed.
- Assessment of ethnic differences in pharmacokinetics and clinical responses of acalabrutinib between Chinese and White patients with B-cell malignancies.British journal of clinical pharmacology · 2025Trial
- Article
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.
Funding
Abstract
aimsThe aim of this study was to assess differences between Chinese and White patients in pharmacokinetics (PK) of, and clinical response to, acalabrutinib and its pharmacologically active major metabolite, ACP-5862, to support recommended dosing in Chinese patients with B-cell malignancies.
methodsA population pharmacokinetic (pop-PK) analysis was conducted to integrate data from a Chinese and a Japanese study into the existing model. The effect of race (East Asian vs. non-East Asian) on acalabrutinib and ACP-5862 PK parameters was assessed. The relationships between model-predicted exposures (e.g., acalabrutinib area under the plasma concentration-time curve for 24 h at steady-state [AUC
resultsThe pop-PK analysis included 686 patients with B-cell malignancies (Chinese, n = 105; Japanese, n = 6). A two-compartment model adequately described the PK profiles of acalabrutinib and ACP-5862 for Chinese patients. East Asian race was a statistically significant covariate on relative bioavailability and apparent volume of the peripheral compartment of acalabrutinib, showing 28% higher PK exposures in Chinese patients. The exposure-efficacy analysis showed that efficacy plateaued in Chinese patients with 100 mg twice-daily dosing while the exposure-safety analysis indicated a flat relationship of acalabrutinib AUC
conclusionsHigher PK exposure was observed in Chinese patients vs. White patients but did not indicate a safety concern based on exposure-response relationships. The results supported using the 100 mg twice-daily dosing regimen in Chinese patients.
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