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Record W4390599050 · doi:10.1002/cpdd.1364

Effect of Tacrolimus Formulation (Prolonged‐Release vs Immediate‐Release) on Its Susceptibility to Drug‐Drug Interactions with St. John's Wort

2024· article· en· W4390599050 on OpenAlexaboutno aff
Katja S. Gümüs, Anna Teegelbekkers, Max Sauter, Andreas D. Meid, Jürgen Burhenne, Johanna Weiß, Antje Blank, Walter E. Haefeli, David Czock

Bibliographic record

VenueClinical Pharmacology in Drug Development · 2024
Typearticle
Languageen
FieldPharmacology, Toxicology and Pharmaceutics
TopicPharmacogenetics and Drug Metabolism
Canadian institutionsnot available
Fundersnot available
KeywordsCYP3ACYP3A4TacrolimusPharmacologyMedicinePharmacokineticsDrug interactionCYP3A5CalcineurinCrossover studyP-glycoproteinPharmacokinetic interactionCmaxInducerCytochrome P450Internal medicineMetabolismChemistryTransplantationAntibioticsBiochemistry

Abstract

fetched live from OpenAlex

Abstract Tacrolimus is metabolized by cytochrome P450 3A (CYP3A) and is susceptible to interactions with the CYP3A and P‐glycoprotein inducer St. John's Wort (SJW). CYP3A isozymes are predominantly expressed in the small intestine and liver. Prolonged‐release tacrolimus (PR‐Tac) is largely absorbed in distal intestinal segments and is less susceptible to CYP3A inhibition. The effect of induction by SJW is unknown. In this randomized, crossover trial, 18 healthy volunteers received single oral tacrolimus doses (immediate‐release [IR]‐Tac or PR‐Tac, 5 mg each) alone and during induction by SJW. Concentrations were quantified using ultra‐high performance liquid chromatography coupled with tandem mass spectrometry and non‐compartmental pharmacokinetics were evaluated. SJW decreased IR‐Tac exposure (area under the concentration‐time curve) to 73% (95% confidence interval 60%‐88%) and maximum concentration (Cmax) to 61% (52%‐73%), and PR‐Tac exposure to 67% (55%‐81%) and Cmax to 69% (58%‐82%), with no statistical difference between the 2 formulations. The extent of interaction appeared to be less pronounced in volunteers with higher baseline CYP3A4 activity and in CYP3A5 expressors. In contrast to CYP3A inhibition, CYP3A induction by SJW showed a similar extent of interaction with both tacrolimus formulations. A higher metabolic baseline capacity appeared to attenuate the extent of induction by SJW.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.002
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.002
Threshold uncertainty score0.006

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0010.002
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.001
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0010.001
Insufficient payload (model declined to judge)0.0020.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.074
GPT teacher head0.473
Teacher spread0.398 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designObservational
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations5
Published2024
Admission routes1
Has abstractyes

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