Effect of OATP1B1/1B3 Inhibitor GDC-0810 on the Pharmacokinetics of Pravastatin and Coproporphyrin I/III in Healthy Female Subjects

Author:

Liu Lichuan1,Cheeti Sravanthi1,Yoshida Kenta1,Choo Edna2,Chen Eugene2,Chen Buyun2,Gates Mary3,Singel Stina3,Morley Roland4,Ware Joseph1,Sahasranaman Srikumar1

Affiliation:

1. Clinical Pharmacology; Genentech Inc.; South San Francisco CA USA

2. Drug Metabolism and Pharmacokinetics; Genentech Inc.; South San Francisco CA USA

3. Early Clinical Development; Genentech Inc.; South San Francisco CA USA

4. Clinical Safety; Genentech Inc.; South San Francisco CA USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference22 articles.

1. Appropriate risk criteria for OATP inhibition at the drug discovery stage based on the clinical relevancy between OATP inhibitors and drug-induced adverse effect;Nakakariya;Drug Metab Pharmacokinet,2016

2. European Medicines Agency Guideline on the investigation of drug interactions http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/07/WC500129606.pdf 2018

3. Food and Drug Administration Guidance for industry: clinical drug interaction studies-study design, data analysis, and clinical implications https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM292362.pdf 2018

4. The application of physiologically based pharmacokinetic modeling to predict the role of drug transporters: scientific and regulatory perspectives;Pan;J Clin Pharmacol,2016

5. Membrane transporters in drug development;Giacomini;Nat Rev Drug Discov,2010

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