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Xenobiotica
the fate of foreign compounds in biological systems
Volume 52, 2022 - Issue 3
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Clinical Pharmacokinetics and Metabolism

Absorption, metabolism, and excretion of [14C]YY-20394, a highly selective PI3K-Delta inhibitor in humans

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Pages 254-264 | Received 04 Mar 2022, Accepted 02 Apr 2022, Published online: 11 Apr 2022

References

  • Ahmad S, Abu-Eid R, Shrimali R, Webb M, Verma V, Doroodchi A, Berrong Z, Samara R, Rodriguez PC, Mkrtichyan M, et al. 2017. Differential PI3Kδ signaling in CD4+ T-cell subsets enables selective targeting of T regulatory cells to enhance cancer immunotherapy. Cancer Res. 77(8):1892–1904.
  • Bertacchini J, Heidari N, Mediani L, Capitani S, Shahjahani M, Ahmadzadeh A, Saki N. 2015. Targeting PI3K/AKT/mTOR network for treatment of leukemia. Cell Mol Life Sci. 72(12):2337–2347.
  • Beumer JH, Beijnen JH, Schellens JHM. 2006. Mass balance studies, with a focus on anticancer drugs. Clin Pharmacokinet. 45(1):33–58.
  • Dhillon S, Keam SJ. 2021. Umbralisib: first approval. Drugs. 81(7):857–866.
  • FDA US 2020. Safety testing of drug metabolites guidance for industry. [accessed 2020 30 April 2020]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-testing-drug-metabolites.
  • Fruman DA, Chiu H, Hopkins BD, Bagrodia S, Cantley LC, Abraham RT. 2017. The PI3K pathway in human disease. Cell. 170(4):605–635.
  • Frustaci AM, Tedeschi A, Deodato M, Zamprogna G, Cairoli R, Montillo M. 2020. Duvelisib for the treatment of chronic lymphocytic leukemia. Expert Opin Pharmacother. 21(11):1299–1309.
  • Furman RR, Sharman JP, Coutre SE, Cheson BD, Pagel JM, Hillmen P, Barrientos JC, Zelenetz AD, Kipps TJ, Flinn I, et al. 2014. Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. N Engl J Med. 370(11):997–1007.
  • Gerisch M, Schwarz T, Lang D, Rohde G, Reif S, Genvresse I, Reschke S, van der Mey D, Granvil C. 2017. Pharmacokinetics of intravenous pan-class I phosphatidylinositol 3-kinase (PI3K) inhibitor [14C]copanlisib (BAY 80-6946) in a mass balance study in healthy male volunteers. Cancer Chemother Pharmacol. 80(3):535–544.
  • Hazenberg MP, Herder WWd, Visser TJ. 1988. Hydrolysis of iodothyronine conjugates by intestinal bacteria. FEMS Microbiol Rev. 4(1):9–16.
  • Hewett YG, Uprety D, Shah BK. 2016. Idelalisib- a PI3Kδ targeting agent for B-cell malignancies. J Oncol Pharm Pract. 22(2):284–288.
  • Hillmann P, Fabbro D. 2019. PI3K/mTOR pathway inhibition: opportunities in oncology and rare genetic diseases. IJMS. 20(22):5792.
  • Jin J, Cen H, Zhou K, Xu X, Li F, Wu T, Yang H, Wang Z, Li Z, Qiu L, et al. 2021. A phase Ib study of a PI3Kδ inhibitor linperlisib in patients with relapsed or refractory peripheral T-cell lymphoma. JCO. 39(15_suppl):7531–7531.
  • Katsuya H, Cook LBM, Rowan AG, Satou Y, Taylor GP, Bangham CRM. 2018. Phosphatidylinositol 3-kinase-δ (PI3K-δ) is a potential therapeutic target in adult T-cell leukemia-lymphoma. Biomark Res. 6:24.
  • Kim DH, Jin YH. 2001. Intestinal bacterial beta-glucuronidase activity of patients with colon cancer. Arch Pharm Res. 24(6):564–567.
  • Krause G, Hassenruck F, Hallek M. 2018. Copanlisib for treatment of B-cell malignancies: the development of a PI3K inhibitor with considerable differences to idelalisib. Drug Des Devel Ther. 12:2577–2590.
  • McGurk KA, Brierley CH, Burchell B. 1998. Drug glucuronidation by human renal UDP-glucuronosyltransferases [Article. Biochem Pharmacol. 55(7):1005–1012.
  • Penner N, Klunk LJ, Prakash C. 2009. Human radiolabeled mass balance studies: objectives, utilities and limitations. Biopharm Drug Dispos. 30(4):185–203.
  • Porta C, Paglino C, Mosca A. 2014. Targeting PI3K/Akt/mTOR signaling in cancer. Front Oncol. 4:64.
  • Qi JY, Song YQ, Jiang B, Li JY, Tu MF, Ping LY, Li ZJ, Xu W, Zhu HY, Zhu J, et al. 2018. Preliminary results from a Phase I, first-in-human study of YY-20394, a highly selective and highly potent PI3Kδ Inhibitor, in patients with relapsed or refractory B-cell malignancies. Blood. 132(Supplement 1):5332–5332.
  • Qiu LG, Qi JY, Song YQ, Jiang B, Tu MF, Ping LY, Li ZJ, Zhu J, Xu YY, Bao HY, et al. 2019. A phase I study of a selective PI3K delta inhibitor YY-20394 in patients with relapsed or refractory B-cell malignancies. J Clin Oncol. 37(15):7563.
  • Strassburg CP, Kneip S, Topp J, Obermayer-Straub P, Barut A, Tukey RH, Manns MP. 2000. Polymorphic gene regulation and interindividual variation of UDP-glucuronosyltransferase activity in human small intestine. J Biol Chem. 275(46):36164–36171.
  • Strassburg CP, Nguyen N, Manns MP, Tukey RH. 1999. UDP-glucuronosyltransferase activity in human liver and colon. Gastroenterology. 116(1):149–160.
  • Tian J, Lei P, He Y, Zhang N, Ge X, Luo L, Yan S, Diao X. 2021. Absorption, distribution, metabolism, and excretion of [14C]NBP (3-n-butylphthalide) in rats. J Chromatogr B Analyt Technol Biomed Life Sci. 1181:122915.
  • Vanhaesebroeck B, Guillermet-Guibert J, Graupera M, Bilanges B. 2010. The emerging mechanisms of isoform-specific PI3K signalling. Nat Rev Mol Cell Biol. 11(5):329–341.
  • Yang QS, Modi P, Newcomb T, Queva C, Gandhi V. 2015. Idelalisib: first-in-class PI3K Delta inhibitor for the treatment of chronic lymphocytic leukemia, small lymphocytic leukemia, and follicular lymphoma. Clin Cancer Res. 21(7):1537–1542.
  • Zheng YD, Zhang H, Zhan Y, Bian YC, Ma S, Gan HX, Lai XJ, Liu YQ, Gong YC, Liu XF, et al. 2021. Pharmacokinetics, mass balance, and metabolism of [14C]vicagrel, a novel irreversible P2Y12 inhibitor in humans. Acta Pharmacol Sin. 42(9):1535–1546.

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