Evidence map›Paper›PMID 33048456›Full record

Trial reportClinical and translational science2021

Coproporphyrin I Can Serve as an Endogenous Biomarker for OATP1B1 Inhibition: Assessment Using a Glecaprevir/Pibrentasvir Clinical Study.

Hari V Kalluri, Ryota Kikuchi, Sheryl Coppola, Jeffrey Schmidt, Mohamed-Eslam F Mohamed, Daniel A J Bow, Ahmed H Salem

Open access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
1.2field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 28 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 1 institution in 2 countries.

Hari V KalluriClinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA.
Ryota KikuchiDrug Metabolism and Pharmacokinetics, AbbVie Inc., North Chicago, Illinois, USA.
Sheryl CoppolaClinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA.
Jeffrey SchmidtDrug Metabolism and Pharmacokinetics, AbbVie Inc., North Chicago, Illinois, USA.
Mohamed-Eslam F MohamedClinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA.
Daniel A J BowDrug Metabolism and Pharmacokinetics, AbbVie Inc., North Chicago, Illinois, USA.
Ahmed H SalemClinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA.
AbbVie (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Organic anion transporting polypeptide (OATP) 1B1 and OATP1B3 are involved in the disposition of a variety of commonly prescribed drugs. The evaluation of OATP1B1/1B3 inhibition potential by investigational drugs is of interest during clinical drug development due to various adverse events associated with increased exposures of their substrates. Regulatory guidance documents on the in vitro assessment of OATP1B1/1B3 inhibition potential are conservative with up to a third of predictions resulting in false positives. This work investigated the utility of OATP1B1/1B3 endogenous biomarkers, coproporphyrin (CP)-I and CP-III, to assess clinical inhibition of OATP1B1/1B3 and potentially eliminate the need for prospective clinical drug-drug interaction (DDI) studies. Correlations between CP-I exposures and various OATP1B1 static DDI predictions were also evaluated. Glecaprevir/pibrentasvir (GLE/PIB) 300/120 mg fixed-dose combination is known to cause clinical inhibition of OATP1B1/1B3. In a clinical study evaluating the relative bioavailability of various formulations of GLE/PIB regimen, CP-I peak plasma concentration (C

Indexed as

AdultArea Under CurveBenzimidazolesBiological AvailabilityBiomarkers, PharmacologicalCoproporphyrinsCross-Over StudiesDrug CombinationsDrug InteractionsDrug MonitoringFemaleHealthy VolunteersHumansLiver-Specific Organic Anion Transporter 1MaleMiddle AgedBenzimidazolesBiomarkers, Pharmacologicalcoproporphyrin Icoproporphyrin IIICoproporphyrinsDrug Combinationsglecaprevir and pibrentasvirLiver-Specific Organic Anion Transporter 1PyrrolidinesQuinoxalinesSLCO1B1 protein, humanSulfonamides

Identifiers

PMID33048456
PMCPMC7877830
OpenAlexW3092587542

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.