Evidence map›Paper›PMID 29920736›Full record

Trial reportBritish journal of clinical pharmacology2018

Coadministration of probenecid and cimetidine with mirogabalin in healthy subjects: A phase 1, randomized, open-label, drug-drug interaction study.

Masaya Tachibana, Naotoshi Yamamura, George J Atiee, Ching Hsu, Vance Warren, Ling He, Victor Dishy, Hamim Zahir

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

Trial report in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.7field-weighted citation impact, top 17% 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

9 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Mirogabalin as a novel calcium channel αFrontiers in pharmacology · 2024
    Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
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

8 authors at 4 institutions in 3 countries.

Masaya TachibanaClinical Pharmacology Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Naotoshi YamamuraDrug Metabolism and Pharmacokinetics Research Laboratories, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
George J AtieeWorldwide Clinical Trials, San Antonio, TX, USA.
Ching HsuDaiichi Sankyo Inc., Basking Ridge, NJ, USA.
Vance WarrenDaiichi Sankyo Inc., Basking Ridge, NJ, USA.
Ling HeDaiichi Sankyo Inc., Basking Ridge, NJ, USA.
Victor DishyDaiichi Sankyo Inc., Basking Ridge, NJ, USA.
Hamim ZahirDaiichi Sankyo Inc., Basking Ridge, NJ, USA.ORCID 0000-0002-2501-5669
Daiichi Sankyo (United States) · USDaiichi Sankyo (Germany) · DEDaiichi-Sankyo (Japan) · JPWorldwide Clinical Trials (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe primary aim of this study was to assess the individual effects of probenecid and cimetidine on mirogabalin exposure.

methodsThis phase 1, open-label, crossover study randomized healthy adults to receive three treatment regimens, each separated by ≥5-day washout: a single oral dose of mirogabalin 15 mg on day 2, mirogabalin 15 mg on day 2 plus probenecid 500 mg every 6 h from days 1 to 4, and mirogabalin 15 mg on day 2 plus cimetidine 400 mg every 6 h from days 1 to 4.

resultsCoadministration of mirogabalin with probenecid or cimetidine increased the maximum and total mirogabalin exposure. The geometric mean ratios of C

conclusionsA greater magnitude of change in mirogabalin exposure was observed when coadministered with a drug that inhibits both renal and metabolic clearance (probenecid) vs. a drug that only affects renal clearance (cimetidine). However, as the increase in exposure is not clinically significant (>2-fold), no a priori dose adjustment is recommended.

Indexed as

Administration, OralAdultArea Under CurveBridged Bicyclo CompoundsCimetidineCross-Over StudiesDiabetic NeuropathiesDose-Response Relationship, DrugDrug InteractionsDrug Therapy, CombinationFemaleHealthy VolunteersHerpes ZosterHumansMaleMetabolic Clearance RateBridged Bicyclo CompoundsCimetidinemirogabalinProbeneciddrug interactionspainpharmacokinetics

Identifiers

PMID29920736
PMCPMC6138503
OpenAlexW2809477671

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.