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Li L, Xiang YX, Yang GP, et al. Pharmacokinetic effects of proton pump inhibitors on the novel PARP inhibitor fluzoparib: a single-arm, fixed-sequence trial in male healthy volunteers. Invest New Drugs. 2021;39(3):796-802doi: 10.1007/s10637-020-01034-w.
Li, L., Xiang, Y. X., Yang, G. P., Zhang, X. F., Yang, X. Y., Yang, S., & Huang, J. (2021). Pharmacokinetic effects of proton pump inhibitors on the novel PARP inhibitor fluzoparib: a single-arm, fixed-sequence trial in male healthy volunteers. Investigational new drugs, 39(3), 796-802. https://doi.org/10.1007/s10637-020-01034-w
Li, Lei, et al. "Pharmacokinetic effects of proton pump inhibitors on the novel PARP inhibitor fluzoparib: a single-arm, fixed-sequence trial in male healthy volunteers." Investigational new drugs vol. 39,3 (2021): 796-802. doi: https://doi.org/10.1007/s10637-020-01034-w
Li L, Xiang YX, Yang GP, Zhang XF, Yang XY, Yang S, Huang J. Pharmacokinetic effects of proton pump inhibitors on the novel PARP inhibitor fluzoparib: a single-arm, fixed-sequence trial in male healthy volunteers. Invest New Drugs. 2021 Jun;39(3):796-802. doi: 10.1007/s10637-020-01034-w. Epub 2021 Jan 09. PMID: 33420642.
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Invest New Drugs. 2021 Jun;39(3):796-802. doi: 10.1007/s10637-020-01034-w. Epub 2021 Jan 09.

Pharmacokinetic effects of proton pump inhibitors on the novel PARP inhibitor fluzoparib: a single-arm, fixed-sequence trial in male healthy volunteers.

Investigational new drugs

Lei Li, Yu-Xia Xiang, Guo-Ping Yang, Xing-Fei Zhang, Xiao-Yan Yang, Shuang Yang, Jie Huang

Affiliations

  1. Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Tongzipo Road, Yuelu District, Hunan, Changsha, 410013, People's Republic of China.
  2. XiangYa School of Pharmaceutical Sciences, Central South University, Changsha, Hunan, 410013, China.
  3. Research Center of Drug Clinical Evaluation of Central South University, Changsha, Hunan, 410013, China.
  4. Department of Pharmacy, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China.
  5. National-Local Joint Engineering Laboratory of Drug Clinical Evaluation Technology, Changsha, Hunan, 410000, China.
  6. Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Tongzipo Road, Yuelu District, Hunan, Changsha, 410013, People's Republic of China. [email protected].
  7. Research Center of Drug Clinical Evaluation of Central South University, Changsha, Hunan, 410013, China. [email protected].
  8. Hunan Key Laboratory Cultivation Base of the Research and Development of Novel Pharmaceutical Preparations, Changsha, Hunan, 410219, China. [email protected].

PMID: 33420642 DOI: 10.1007/s10637-020-01034-w

Abstract

Purpose To assess the pharmacokinetic (PK) effect of proton pump inhibitors on the novel poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitor fluzoparib, and observe the safety of its co-administration with omeprazole. Patients and methods Sixteen male healthy volunteers (HVs) were enrolled in a single-center, single-arm, open-label, fixed-sequence study. HVs took fluzoparib (100 mg, p.o.) after meal consumption on day-1, took omeprazole 40 mg (p.o.) under a fasting condition from day-5 to day-9, and took fluzoparib (100 mg, p.o.) after meal consumption on day-9. Blood samples were collected at predetermined timepoints for PK analyses. Safety was assessed via clinical laboratory tests. The study was registered with the Clinical Trials Registry on 30 September 2019 (NCT04108676). Results The peak plasma concentrations (C

Keywords: Drug–drug interaction; PARP inhibitor; Pharmacokinetics; Proton pump inhibitor; Safety

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