Evidence map›Paper›PMID 31856304›Full record

ArticleBritish journal of clinical pharmacology2020

Impact of renal impairment and human organic anion transporter inhibition on pharmacokinetics, safety and tolerability of relebactam combined with imipenem and cilastatin.

Pratik Bhagunde, Francheska Colon-Gonzalez, Yang Liu, Jin Wu, Shiyao Sherrie Xu, Graigory Garrett, Patricia Jumes, Kenneth Lasseter, Thomas Marbury, Matthew L Rizk and 4 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in British journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01275170 (A Single-Dose Study to Investigate the Pharmacokinetics of MK-7655 in Subjects With Impaired Renal Function), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.7field-weighted citation impact, top 26% 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.

NCT01275170 phase1completednot on this map

A Single-Dose Study to Investigate the Pharmacokinetics of MK-7655 in Subjects With Impaired Renal Function

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2011 to 2012Enrolled49ConditionsInfectious DiseaseArmsMK-7655, Imipenem + Cilastatin, Caffeine, Midazolam, Omeprazole
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 13 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Review
  5. New Perspectives on Antimicrobial Agents: Imipenem-Relebactam.Antimicrobial agents and chemotherapy · 2022
    Review
  6. Review
  7. Review
  8. Article
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

14 authors at 3 institutions in 1 country.

Pratik BhagundeMerck & Co., Inc., Kenilworth, NJ, USA.
Francheska Colon-GonzalezMerck & Co., Inc., Kenilworth, NJ, USA.
Yang LiuMerck & Co., Inc., Kenilworth, NJ, USA.
Jin WuMerck & Co., Inc., Kenilworth, NJ, USA.
Shiyao Sherrie XuMerck & Co., Inc., Kenilworth, NJ, USA.
Graigory GarrettMerck & Co., Inc., Kenilworth, NJ, USA.
Patricia JumesMerck & Co., Inc., Kenilworth, NJ, USA.
Kenneth LasseterClinical Pharmacology of Miami, LLC, Miami, FL, USA.
Thomas MarburyOrlando Clinical Research Center, Orlando, FL, USA.
Matthew L RizkMerck & Co., Inc., Kenilworth, NJ, USA.
Mallika LalaMerck & Co., Inc., Kenilworth, NJ, USA.
Elizabeth G RheeMerck & Co., Inc., Kenilworth, NJ, USA.
Joan R ButtertonMerck & Co., Inc., Kenilworth, NJ, USA.
Keith BoundyMerck & Co., Inc., Kenilworth, NJ, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USClinical Pharmacology of Miami · USOrlando Clinical Research Center · US

Funding

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (MSD)
6 · The paper itself

Abstract

aimsTwo phase 1, open-label studies were conducted to investigate the effect of renal impairment (RI) and organic anion transporter (OAT) inhibition on pharmacokinetics (PK) and safety of relebactam (REL) plus imipenem/cilastatin (IMI).

methodsStudy PN005 evaluated the PK of REL (125 mg) plus IMI (250 mg) in participants with RI vs healthy controls. Study PN019 evaluated the PK of REL (250 mg) and imipenem (500 mg; dosed as IMI) with/without probenecid (1 g; OAT inhibitor) in healthy adults.

resultsGeometric mean ratios (RI/healthy matched controls) of area under the concentration-time curve from time 0 to infinity (AUC

conclusionRI increased plasma exposure and similarly decreased clearance of REL, imipenem and cilastatin; IMI/REL dose adjustment (fixed-ratio) will be required for patients with RI. Probenecid had no clinically meaningful impact on the PK of REL or imipenem.

Indexed as

Azabicyclo Compoundsbeta-Lactamase InhibitorsOrganic Anion TransportersRenal InsufficiencyAdultAgedCilastatinDrug CombinationsFemaleHumansImipenemMaleMiddle AgedYoung AdultAzabicyclo Compoundsbeta-Lactamase InhibitorsCilastatinDrug CombinationsImipenemOrganic Anion Transportersrelebactamantibioticsdrug transporterspharmacokineticsphase 1

Identifiers

PMID31856304
PMCPMC7163372
OpenAlexW2995259864

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.