دورية أكاديمية
Effect of Strong CYP3A4 Inhibition, CYP3A4 Induction, and OATP1B1/3 Inhibition on the Pharmacokinetics of a Single Oral Dose of Sotorasib.
العنوان: | Effect of Strong CYP3A4 Inhibition, CYP3A4 Induction, and OATP1B1/3 Inhibition on the Pharmacokinetics of a Single Oral Dose of Sotorasib. |
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المؤلفون: | Cardona P; Clinical Pharmacology, Modeling and Simulation, Amgen Inc., Thousand Oaks, CA, USA., Dutta S; Clinical Pharmacology, Modeling and Simulation, Amgen Inc., Thousand Oaks, CA, USA., Houk B; Clinical Pharmacology, Modeling and Simulation, Amgen Inc., Thousand Oaks, CA, USA. |
المصدر: | Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2024 Jul; Vol. 13 (7), pp. 810-818. Date of Electronic Publication: 2024 Feb 29. |
نوع المنشور: | Journal Article; Clinical Trial, Phase I; Randomized Controlled Trial |
اللغة: | English |
بيانات الدورية: | Publisher: Wiley Country of Publication: United States NLM ID: 101572899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2160-7648 (Electronic) Linking ISSN: 2160763X NLM ISO Abbreviation: Clin Pharmacol Drug Dev Subsets: MEDLINE |
أسماء مطبوعة: | Publication: 2013- : Hoboken, NJ : Wiley Original Publication: Thousand Oaks, Calif. : Sage Publications, c2012- |
مواضيع طبية MeSH: | Liver-Specific Organic Anion Transporter 1*/antagonists & inhibitors , Liver-Specific Organic Anion Transporter 1*/metabolism , Solute Carrier Organic Anion Transporter Family Member 1B3*/antagonists & inhibitors , Solute Carrier Organic Anion Transporter Family Member 1B3*/metabolism , Cytochrome P-450 CYP3A Inhibitors*/pharmacology , Cytochrome P-450 CYP3A Inhibitors*/administration & dosage , Cytochrome P-450 CYP3A*/metabolism , Rifampin*/pharmacology , Rifampin*/administration & dosage , Drug Interactions* , Cytochrome P-450 CYP3A Inducers*/pharmacology, Humans ; Male ; Adult ; Female ; Young Adult ; Administration, Oral ; Middle Aged ; Healthy Volunteers ; Area Under Curve ; Itraconazole/pharmacology ; Itraconazole/administration & dosage ; Itraconazole/pharmacokinetics ; Spiro Compounds/pharmacokinetics ; Spiro Compounds/administration & dosage ; Spiro Compounds/pharmacology |
مستخلص: | Sotorasib is a small molecule that irreversibly inhibits the Kirsten rat sarcoma viral oncogene homolog (KRAS) protein with a G12C amino acid substitution mutant protein. The impact of cytochrome P450 (CYP) 3A4 inhibition and induction on sotorasib pharmacokinetics (PKs) was evaluated in 2 separate studies in healthy volunteers (N = 14/study). The impact of CYP3A4 inhibition was interrogated utilizing repeat doses of 200 mg of itraconazole, a strong CYP3A4 inhibitor, on 360 mg of sotorasib PKs. The impact of CYP3A4 induction was interrogated utilizing multiple doses of 600 mg of rifampin, a strong CYP3A4 inducer. Additionally, the impact of organic anion transporting polypeptide (OATP) 1B1/3 inhibition on 960 mg of sotorasib PKs was interrogated after a single dose of 600 mg of rifampin. CYP3A4 inhibition did not significantly impact sotorasib C (© 2024, The American College of Clinical Pharmacology.) |
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فهرسة مساهمة: | Keywords: CYP3A4; KRAS inhibitor; drug interaction; oncology; sotorasib |
المشرفين على المادة: | 0 (Liver-Specific Organic Anion Transporter 1) 0 (SLCO1B1 protein, human) 0 (Solute Carrier Organic Anion Transporter Family Member 1B3) 0 (Cytochrome P-450 CYP3A Inhibitors) 0 (SLCO1B3 protein, human) EC 1.14.14.1 (Cytochrome P-450 CYP3A) VJT6J7R4TR (Rifampin) 0 (Cytochrome P-450 CYP3A Inducers) EC 1.14.14.55 (CYP3A4 protein, human) 304NUG5GF4 (Itraconazole) 0 (Spiro Compounds) |
تواريخ الأحداث: | Date Created: 20240229 Date Completed: 20240703 Latest Revision: 20240703 |
رمز التحديث: | 20240704 |
DOI: | 10.1002/cpdd.1392 |
PMID: | 38421129 |
قاعدة البيانات: | MEDLINE |
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