A Colon‐Targeted Adsorbent (DAV132) Does Not Affect the Pharmacokinetics of Warfarin or Clonazepam in Healthy Subjects
Bibliographic record
Abstract
Abstract DAV132 is a novel colon‐targeted adsorbent that prevents the deleterious impact of antibiotics on gut microbiota without modifying their systemic availability. A randomized, Latin‐square crossover, open‐label trial with 2 substudies in 18 and 24 healthy volunteers evaluated the pharmacokinetic (PK) bioequivalence of warfarin, a drug with a narrow therapeutic index (NTI), and clonazepam, both widely used for the treatment of chronic conditions, with or without coadministration of DAV132 7.5 g. PK parameters observed with single doses of 5 mg warfarin and 1 mg clonazepam when administered alone did not differ with the PK parameters when administered concomitantly with or 1 hour before DAV132. Geometric mean ratios (GMRs) for S‐warfarin, R‐warfarin, and clonazepam C max were 102.0, 102.8, and 91.9, respectively, after concomitant administration and 106.5, 107.5, and 95.0, respectively, when administered 1 hour before DAV132. After concomitant administration, GMRs for S‐warfarin, R‐warfarin, and clonazepam AUC last were 100.5, 100.2, and 94.9, respectively, and 101.9, 101.8, and 101.3, respectively, when administered 1 hour before DAV132. All GMR 90% confidence intervals fell within the prespecified 80% to 125% limit for bioequivalence, indicating a lack of drug‐drug interaction. In conclusion, DAV132 did not affect the systemic exposure of 2 NTI drugs absorbed in the proximal intestine.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.004 | 0.000 |
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.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
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".