دورية أكاديمية
A Phase 1, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics of Iberdomide in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared with Healthy Subjects
| العنوان: | A Phase 1, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics of Iberdomide in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared with Healthy Subjects |
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| المؤلفون: | Cheng,Yiming, Ye,Ying, Gaudy,Allison, Ghosh,Atalanta, Xue,Yongjun, Wang,Alice, Zhou,Simon, Li,Yan |
| بيانات النشر: | Dove Press |
| سنة النشر: | 2023 |
| المجموعة: | Dove Medical Press |
| مصطلحات موضوعية: | Clinical Pharmacology: Advances and Applications |
| الوصف: | Yiming Cheng,1 Ying Ye,1 Allison Gaudy,1 Atalanta Ghosh,2 Yongjun Xue,3 Alice Wang,1 Simon Zhou,1 Yan Li1 1Clinical Pharmacology & Pharmacometrics, Bristol Myers Squibb, Princeton, NJ, USA; 2Global Biometrics and Data Sciences, Bristol Myers Squibb, Princeton, NJ, USA; 3Nonclinical Research & Development, Bristol Myers Squibb, Princeton, NJ, USACorrespondence: Yan Li, Clinical Pharmacology & Pharmacometrics, Bristol Myers Squibb, 556 Morris Ave, Summit, Princeton, NJ, 07901, USA, Tel +1 908-481-6203, Email Yan.Li@bms.comIntroduction: Iberdomide, a novel cereblon modulator (CELMoD®), is currently under clinical investigation for hematology indications. To evaluate the influence of hepatic impairment on the pharmacokinetics (PK) of iberdomide and its major active metabolite M12, a phase 1, multicenter, open-label study was conducted in healthy subjects and subjects with mild, moderate, and severe hepatic impairment.Methods: Forty subjects were enrolled in the study and divided into five groups based on hepatic function. 1 mg iberdomide was administered and plasma samples were collected to evaluate the pharmacokinetics of iberdomide and M12.Results: After a single dose of iberdomide (1 mg), mean iberdomide Cmax (maximum observed concentration) and AUC (area under the concentration-time curve) exposure were generally comparable between hepatic impairment (HI) subjects (severe, moderate and mild) and their respective matched normal controls. Mean Cmax and AUC exposure of the metabolite M12 were generally comparable between mild HI and matched normal subjects. However, mean Cmax of the M12 was 30% and 65% lower and AUC was 57% and 63% lower in moderate and severe HI subjects as compared to their respective matched normal controls. However, given the relatively low M12 exposure as compared to its parent drug, the observed differences were not considered clinically meaningful.Conclusion: In summary, 1 mg single oral dose of iberdomide was generally well-tolerated. HI (mild, moderate or severe) had no ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | text/html |
| اللغة: | English |
| العلاقة: | https://www.dovepress.com/a-phase-1-multicenter-open-label-study-to-evaluate-the-pharmacokinetic-peer-reviewed-fulltext-article-CPAATest |
| الإتاحة: | https://doi.org/10.2147/CPAA.S397826Test https://www.dovepress.com/a-phase-1-multicenter-open-label-study-to-evaluate-the-pharmacokinetic-peer-reviewed-fulltext-article-CPAATest |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.2C67FA51 |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |