Effect of Cyclosporin A and Impact of Dose Staggering on OATP1B1/1B3 Endogenous Substrates and Drug Probes for Assessing Clinical Drug Interactions.


Journal

Clinical pharmacology and therapeutics
ISSN: 1532-6535
Titre abrégé: Clin Pharmacol Ther
Pays: United States
ID NLM: 0372741

Informations de publication

Date de publication:
06 2022
Historique:
received: 03 08 2021
accepted: 28 02 2022
pubmed: 17 3 2022
medline: 21 5 2022
entrez: 16 3 2022
Statut: ppublish

Résumé

This study was designed to assess the quantitative performance of endogenous biomarkers for organic anion transporting polypeptide (OATP) 1B1/1B3-mediated drug-drug interactions (DDIs). Ten healthy volunteers orally received OATP1B1/1B3 probe cocktail (0.2 mg pitavastatin, 1 mg rosuvastatin, and 2 mg valsartan) and an oral dose of cyclosporin A (CysA, 20 mg and 75 mg) separated by a 1-hour interval (20 mg (-1 hour), and 75 mg (-1 hour)). CysA 75 mg was also given with a 3-hour interval (75 mg (-3 hours)) to examine the persistence of OATP1B1/1B3 inhibition. The area under the plasma concentration-time curve ratios (AUCRs) were 1.63, 3.46, and 2.38 (pitavastatin), 1.39, 2.16, and 1.81 (rosuvastatin), and 1.42, 1.77, and 1.85 (valsartan), at 20 mg, 75 mg (-1 hour) and 75 mg (-3 hours) of CysA, respectively. CysA effect on OATP1B1/1B3 was unlikely to persist at the dose examined. Among 26 putative OATP1B1/1B3 biomarkers evaluated, AUCR and maximum concentration ratio (C

Identifiants

pubmed: 35292967
doi: 10.1002/cpt.2584
pmc: PMC9325410
doi:

Substances chimiques

Liver-Specific Organic Anion Transporter 1 0
Organic Anion Transporters 0
Solute Carrier Organic Anion Transporter Family Member 1B3 0
Valsartan 80M03YXJ7I
Cyclosporine 83HN0GTJ6D
Rosuvastatin Calcium 83MVU38M7Q

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1315-1323

Informations de copyright

© 2022 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.

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Auteurs

Tatsuki Mochizuki (T)

Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan.

Maciej J Zamek-Gliszczynski (MJ)

Drug Metabolism and Disposition, GlaxoSmithKline, Collegeville, Pennsylvania, USA.

Kenta Yoshida (K)

Clinical Pharmacology, Genentech, Inc., South San Francisco, California, USA.

Jialin Mao (J)

Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San Francisco, California, USA.

Kunal Taskar (K)

Drug Metabolism and Disposition, GlaxoSmithKline, Stevenage, UK.

Hideki Hirabayashi (H)

Drug Metabolism and Pharmacokinetics Research Laboratories, Research, Takeda Pharmaceutical Company Limited, Kanagawa, Japan.

Xiaoyan Chu (X)

Merck & Co., Inc., Rahway, New Jersey, USA.

Yurong Lai (Y)

Drug Metabolism Department, Gilead Sciences Inc., Foster City, California, USA.

Tadayuki Takashima (T)

Laboratory for Safety Assessment & ADME, Pharmaceuticals Research Center, Asahi Kasei Pharma Corporation, Shizuoka, Japan.

Kevin Rockich (K)

Drug Metabolism, Pharmacokinetics and Clinical Pharmacology, Incyte Research Institute, Wilmington, Delaware, USA.

Yoshiyuki Yamaura (Y)

Pharmacokinetic Research Laboratories, Ono Pharmaceutical Co., Ltd, Osaka, Japan.

Kaku Fujiwara (K)

Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan.

Tadahaya Mizuno (T)

Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan.

Kazuya Maeda (K)

Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan.

Kenichi Furihata (K)

P-One Clinic, Keikokai Medical Corp., Tokyo, Japan.

Yuichi Sugiyama (Y)

Sugiyama Laboratory, RIKEN Baton Zone Program, RIKEN Cluster for Science, Technology and Innovation Hub, RIKEN, Yokohama, Kanagawa, Japan.

Hiroyuki Kusuhara (H)

Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan.

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Classifications MeSH