ArticleClinical and translational science2026
Physiologically Based Pharmacokinetic Modeling to Predict Human Starting Dose and Pharmacokinetics for Rocbrutinib.
Article in Clinical and translational science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
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
7 authors.
Funding
Abstract
Rocbrutinib is a fourth-generation Bruton's tyrosine kinase (BTK) inhibitor that covalently binds wild-type BTK and non-covalently engages the C481S mutant. Its pharmacokinetic (PK) characteristics in healthy Chinese subjects remain unclear. This study aimed to support maximum recommended starting dose (MRSD) selection and predict exposure of rocbrutinib in healthy Chinese subjects via an integrated model-informed strategy. We determined key extrapolation parameters and preclinical PK in CD-1 mice and beagle dogs. Three approaches were employed to determine the MRSD: The no observed adverse effect level (NOAEL) dose method based on body surface area, the NOAEL exposure method based on a physiologically based pharmacokinetic (PBPK) model, and the minimum effective dose method based on a PBPK model. The PBPK model was developed and validated using preclinical and clinical PK data. Predicted MRSD values by the NOAEL dose method, the NOAEL exposure method, and the minimum effective dose method were 48.7, 9.8, and 10.5 mg, respectively. Considering the lowest predicted value and available tablet strength, a starting dose of 12.5 mg was selected. Predicted plasma concentration-time profiles were consistent with those observed in animals and humans. The fold error for C
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.