Evidence map›Paper›PMID 29950814›Full record

Trial reportDrug design, development and therapy2018

Pharmacokinetics, pharmacodynamics, and tolerability of verinurad, a selective uric acid reabsorption inhibitor, in healthy Japanese and non-Asian male subjects.

Jesse Hall, Michael Gillen, Sha Liu, Jeffrey N Miner, Shakti Valdez, Zancong Shen, Caroline Lee

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

Trial report in Drug design, development and therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.3field-weighted citation impact, top 23% 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

7 citing papers in PubMed, 10 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 3 countries.

Jesse HallArdea Biosciences, Inc., San Diego, CA, USA.
Michael GillenAstraZeneca, Gaithersburg, MD, USA.
Sha LiuArdea Biosciences, Inc., San Diego, CA, USA.
Jeffrey N MinerArdea Biosciences, Inc., San Diego, CA, USA.
Shakti ValdezArdea Biosciences, Inc., San Diego, CA, USA.
Zancong ShenArdea Biosciences, Inc., San Diego, CA, USA.
Caroline LeeArdea Biosciences, Inc., San Diego, CA, USA.
AstraZeneca (Netherlands) · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeVerinurad (RDEA3170) is a selective uric acid reabsorption inhibitor in clinical development for treatment of gout and asymptomatic hyperuricemia. This study evaluated verinurad pharmacokinetics, pharmacodynamics, and tolerability in healthy Japanese and non-Asian adult male subjects.

methodsThis was a Phase I, randomized, single-blind, placebo-controlled study. Panels of 8 Japanese subjects were randomized to receive oral verinurad (2.5-15 mg) or placebo administered as a single dose in a fasted and fed state and as once-daily doses for 7 days in a fed state. Eight non-Asian subjects received verinurad 10 mg as a single dose (fasted and fed) and multiple doses in the fed state. Serial plasma/serum and urine samples were assayed for verinurad and uric acid. Safety was assessed by adverse events and laboratory data.

resultsOf 48 randomized subjects, 46 (Japanese, 39; non-Asian, 7) completed the study. Following single or multiple doses in Japanese subjects, maximum plasma concentration (

conclusionVerinurad monotherapy lowered serum urate and was well tolerated in both healthy Japanese and non-Asian males, while small differences in plasma pharmacokinetics were observed. These data support further evaluation of once-daily verinurad as a treatment for gout and asymptomatic hyperuricemia.

Indexed as

Asian PeopleNaphthalenesPropionatesPyridinesAdministration, OralAdultArea Under CurveDrug Administration ScheduleHalf-LifeHealthy VolunteersHumansKidney TubulesMaleMetabolic Clearance RateMiddle AgedModels, BiologicalNaphthalenesPropionatesPyridinesUric AcidUricosuric Agentsverinuradpharmacodynamicspharmacokineticsselective uric acid reabsorption inhibitorserum urateurinary uric acid

Identifiers

PMID29950814
PMCPMC6018888
OpenAlexW2809403952

What OpenQuestion holds

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LicenceCC BY-NC
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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.