Assessment of Pharmacokinetic Drug Interaction of Asciminib with Atorvastatin in Healthy Participants
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Le résumé fourni par la source
Abstract Asciminib is the first BCR::ABL1 inhibitor that Specifically Targets the ABL Myristoyl Pocket (STAMP) in patients with chronic myeloid leukemia. This phase 1, two‐treatment‐period, drug‐drug interaction study evaluated the effect of steady‐state asciminib on the pharmacokinetics of atorvastatin. A single dose of atorvastatin (20 mg) was administered on day 1 (period 1: days 1‐4). On days 5‐11 (period 2: days 5‐12), 80 mg asciminib was administered once daily, with a single dose of atorvastatin co‐administered on day 9. Pharmacokinetic sampling for atorvastatin was performed on days 1‐4 in period 1 and days 9‐12 in period 2. Twenty‐two healthy participants were enrolled. Twenty participants completed the study, and two discontinued due to adverse events (AEs). Asciminib increased the adjusted geometric mean (G mean ) of maximum plasma concentration (C max ), the area under the curve (AUC) from zero to the last quantifiable concentration (AUC last ), and the AUC from zero to infinity (AUC inf ) of atorvastatin by 24%, 16%, and 14%, respectively, and did not affect these parameters for its active metabolites, o ‐hydroxy‐atorvastatin and p ‐hydroxy‐atorvastatin. Plasma concentrations of coproporphyrin‐1 (CP‐1), an endogenous substrate of the atorvastatin transporter OATP1B, were not affected by asciminib. Thirteen participants reported at least one AE, all being grade 1/2, except for one grade 3 AE (increased alanine aminotransferase). No serious AEs were reported. In conclusion, concomitant administration of steady‐state asciminib and atorvastatin resulted in a small, clinically irrelevant increase in atorvastatin exposure and no change in CP‐1 concentrations. Both drugs were well tolerated. These data support co‐administration of asciminib and atorvastatin.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Assessment of Pharmacokinetic Drug Interaction of Asciminib with Atorvastatin in Healthy Participants
- Date Crossref
- 22/10/2025
- Éditeur
- Wiley
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Novartis (Switzerland) pays non établi dans la noticeEntreprise
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Novartis (United States) pays non établi dans la noticeEntreprise
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Novartis (India) pays non établi dans la noticeEntreprise
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Novartis Biomedical Research Basel Switzerland pays non établi dans la noticeInstitution
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Novartis Pharmaceuticals East Hanover New Jersey USA pays non établi dans la noticeInstitution
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Novartis Healthcare Pvt Ltd Hyderabad India pays non établi dans la noticeEntreprise
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Novartis Pharma AG Basel Switzerland pays non établi dans la noticeInstitution
Novartis (Switzerland), Novartis (United States) et Novartis (India), avec 4 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.