Development of an LC–MS method to quantify coproporphyrin I and III as endogenous biomarkers for drug transporter-mediated drug-drug interactions

Ediage, Emmanuel Njumbe; Dillen, Lieve; Vroman, Ann; Diels, Luc; Kunze, Annett; Snoeys, Jan; Verhaeghe, Tom

doi:10.1016/j.jchromb.2017.12.008

Cited by 15 publications

(20 citation statements)

References 24 publications

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“…In this large‐scale study in the Japanese general population, the mean plasma CP‐I concentration was 0.48 ng/mL. This value was slightly lower compared with previous studies in the white population (mean concentration: 0.60–0.71 ng/mL) 49 . The difference might be due to genetic differences, such as OATP1B1 polymorphism, but the detail mechanism is unknown.…”

Section: Discussioncontrasting

confidence: 72%

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Substantially Increased Plasma Coproporphyrin‐I Concentrations Associated With OATP1B115* Allele in Japanese General Population

Suzuki

Sasamoto

Koyama

et al. 2020

Clinical Translational Sci

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Coproporphyrin-I (CP-I) in plasma is a sensitive and specific endogenous probe for phenotyping organic anion transporting polypeptides 1B (OATP1B, encoded by SLCO1B). A few small-scale studies suggested that plasma CP-I concentration is affected by OATP1B1 polymorphism, but detailed studies are lacking. In this large-scale study, we measured plasma CP-I concentrations in 391 subjects from the Japanese general population, and evaluated the relationship between plasma CP-I concentrations and OATP1B1 polymorphisms to further assess the utility of plasma CP-I concentrations as an endogenous OATP1B probe. Plasma CP-I concentrations were 0.45 ± 0.12, 0.47 ± 0.16, 0.47 ± 0.20, 0.50 ± 0.15, 0.54 ± 0.14, and 0.74 ± 0.31 ng/mL in participants with OATP1B1*1b/*1b (n = 103), *1a/*1b (n = 122), *1a/*1a (n = 40), *1b/*15 (n = 74), *1a/*15 (n = 41), and *15/*15 (n = 11), respectively, showing an ascending rank order with significant difference (P < 0.0001). Post hoc analysis revealed significant increases in plasma CP-I concentration in OATP1B1*1b/*15 (P = 0.036), *1a/*15 (P = 0.0005), and *15/*15 (P = 0.0003) groups compared with the OATP1B1*1b/*1b group. There was no significant difference among OATP1B genotypes in plasma concentration of 3-carboxy-4-methyl-5-propyl-2-furanpropanoic acid, a uremic toxin reported to decrease OATP1B activity in vivo. These findings confirm the utility of plasma CP-I concentrations as an endogenous biomarker for phenotyping of OATP1B activity. Plasma CP-I concentration is potentially useful for the study of drug-drug interactions via OATP1B or individual dose adjustment of OATP1B substrates. Drug transporters are localized at cell membranes and involved in drug transport in various tissues such as the liver, kidneys, gastrointestinal tract, and brain endothelium. Organic anion transporting polypeptides 1B (OATP1B, encoded by SLCO1B) is a hepatic uptake transporter that substantially affect pharmacokinetics of some drugs, such as hydroxymethylglutaryl (HMG)-CoA reductase inhibitors and some anti-hepatitis C virus drugs. 1-6 In vivo OATP1B activity has large interindividual variability and is affected by environmental, physiologic, and genetic factors. For example, OATP inhibitors, such as rifampicin and cyclosporin A, inhibit OATP1B activity and increase plasma concentrations

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Section: Discussioncontrasting

confidence: 72%

“…This value was slightly lower compared with previous studies in the white population (mean concentration: 0.60-0.71 ng/mL). 49 The difference might be due to genetic differences, such as OATP1B1 polymorphism, but the detail mechanism is unknown. Further studies are needed to reveal the racial differences of plasma CP-I concentrations.…”

Section: Discussionmentioning

confidence: 99%

Substantially Increased Plasma Coproporphyrin‐I Concentrations Associated With OATP1B115* Allele in Japanese General Population

Suzuki

Sasamoto

Koyama

et al. 2020

Clinical Translational Sci

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“…Rapidly advancing drug transporter [30] and CYP [31] biomarker sciences suggest that selected endogenous compounds, detectable in human plasma and urine, may serve as biomarkers for specific transporters and CYPs. Among them, coproporphyrin isomers [32,33], coproporphyrin-I (CP-I) and coproporphyrin-III (CP-III), bile acids [34], and N1-methylnicotinamide (NMN) [35] have been evaluated as possible candidate biomarkers for organic anion-transporting polypeptides (OATP1B1 and OATP1B3), organic cation transporters (OCT1 and OCT2), and MATEs, respectively. In a similar fashion, 4-beta-hydroxycholesterol (4beta-HC) and 25hydroxycholesterol (25-HC) have been evaluated as possible endogenous biomarkers for CYP3A4 [31].…”

Section: Small Molecule Biomarkers By Lcms Hrms For Small Molecule Biomarkersmentioning

confidence: 99%

2019 White Paper on Recent Issues in Bioanalysis: Chromatographic Assays (Part 1 – Innovation in Small Molecules and Oligonucleotides & Mass Spectrometric Method Development Strategies for Large Molecule Bioanalysis)

et al. 2019

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The 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) took place in New Orleans, LA, USA on April 1–5, 2019 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event – a full immersion week of bioanalysis, biomarkers, immunogenicity and gene therapy. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule bioanalysis involving LCMS, hybrid LBA/LCMS, LBA cell-based/flow cytometry assays and qPCR approaches. This 2019 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2019 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 1) covers the recommendations on Innovation in Small Molecules and Oligonucleotides & Mass Spec Method Development Strategies for Large Molecules Bioanalysis. Part 2 (2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and regulatory agencies' input on bioanalysis, biomarkers, immunogenicity and gene therapy) and Part 3 (New Insights in Biomarkers Assays Validation, Current & Effective Strategies for Critical Reagent Management, Flow Cytometry Validation in drug discovery & development & CLSI H62, Interpretation of the 2019 FDA Immunogenicity Guidance and The Gene Therapy Bioanalytical Challenges) are published in volume 11 of Bioanalysis, issues 23 and 24 (2019), respectively.

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“…The preferred approach for early stage exploratory biomarker work is to use multiplexed HRMS assays for profiling multiple endogenous biomarkers [45]. The development of a highly selective and sensitive UHPLC-HRMS assay affords options for earlier characterization and clinical safety projections for OATP1B1/3 [45][46][47][48][49], selected bile acids [50] and NMN-mediated DDIs [51] along with pharmacokinetic analyses of drugs as part of FIH clinical studies. In MS-based methods, it is preferred to use SIL-IS for each endogenous biomarker; however, structural analogues can be used as an alternative as long as they are properly validated.…”

Section: Endogenous Small Molecule Biomarkers For Renal and Hepatic Transportersmentioning

confidence: 99%

2018 White Paper on Recent Issues in Bioanalysis: ‘A Global Bioanalytical Community Perspective on Last Decade of Incurred Samples Reanalysis (ISR)’ (Part 1 – Small Molecule Regulated Bioanalysis, Small Molecule Biomarkers, Peptides & Oligonucleotide Bioanalysis)

Welink¹,

Yang

et al. 2018

Bioanalysis

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The 2018 12 th Workshop on Recent Issues in Bioanalysis (12th WRIB) took place in Philadelphia, PA, USA on April 9-13, 2018 with an attendance of over 900 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day full immersion in bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small-and largemolecule bioanalysis involving LC-MS, hybrid ligand binding assay (LBA)/LC-MS and LBA/cell-based assays approaches. This 2018 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2018 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 1) covers the recommendations for LC-MS for small molecules, peptides, oligonucleotides and small molecule biomarkers. Part 2 (hybrid LBA/LC-MS for biotherapeutics and regulatory agencies' inputs) and Part 3 (large molecule bioanalysis, biomarkers and immunogenicity using LBA and cell-based assays) are published in volume 10 of Bioanalysis, issues 23 and 24 (2018), respectively.

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Development of an LC–MS method to quantify coproporphyrin I and III as endogenous biomarkers for drug transporter-mediated drug-drug interactions

Cited by 15 publications

References 24 publications

Substantially Increased Plasma Coproporphyrin‐I Concentrations Associated With OATP1B115* Allele in Japanese General Population

Substantially Increased Plasma Coproporphyrin‐I Concentrations Associated With OATP1B115* Allele in Japanese General Population

2019 White Paper on Recent Issues in Bioanalysis: Chromatographic Assays (Part 1 – Innovation in Small Molecules and Oligonucleotides & Mass Spectrometric Method Development Strategies for Large Molecule Bioanalysis)

2018 White Paper on Recent Issues in Bioanalysis: ‘A Global Bioanalytical Community Perspective on Last Decade of Incurred Samples Reanalysis (ISR)’ (Part 1 – Small Molecule Regulated Bioanalysis, Small Molecule Biomarkers, Peptides & Oligonucleotide Bioanalysis)

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Development of an LC–MS method to quantify coproporphyrin I and III as endogenous biomarkers for drug transporter-mediated drug-drug interactions

Cited by 15 publications

References 24 publications

Substantially Increased Plasma Coproporphyrin‐I Concentrations Associated With OATP1B1*15 Allele in Japanese General Population

Substantially Increased Plasma Coproporphyrin‐I Concentrations Associated With OATP1B1*15 Allele in Japanese General Population

2019 White Paper on Recent Issues in Bioanalysis: Chromatographic Assays (Part 1 – Innovation in Small Molecules and Oligonucleotides & Mass Spectrometric Method Development Strategies for Large Molecule Bioanalysis)

2018 White Paper on Recent Issues in Bioanalysis: ‘A Global Bioanalytical Community Perspective on Last Decade of Incurred Samples Reanalysis (ISR)’ (Part 1 – Small Molecule Regulated Bioanalysis, Small Molecule Biomarkers, Peptides & Oligonucleotide Bioanalysis)

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Substantially Increased Plasma Coproporphyrin‐I Concentrations Associated With OATP1B115* Allele in Japanese General Population

Substantially Increased Plasma Coproporphyrin‐I Concentrations Associated With OATP1B115* Allele in Japanese General Population