Evidence map›Paper›PMID 27209291›Full record

Trial reportClinical pharmacokinetics2016

Population Pharmacokinetic and Pharmacodynamic Modeling of Lusutrombopag, a Newly Developed Oral Thrombopoietin Receptor Agonist, in Healthy Subjects.

Takayuki Katsube, Toru Ishibashi, Takeshi Kano, Toshihiro Wajima

Abstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

19 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  7. [Clinical research progress of lusutrombopag for the treatment of thrombocytopenia in chronic liver disease].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2024
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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

4 authors.

Takayuki KatsubeClinical Research Department, Shionogi & Co., Ltd., 1-1-4 Shibata, Kita-ku, Osaka, 530-0012, Japan. takayuki.katsube@shionogi.co.jp.
Toru IshibashiClinical Research Department, Shionogi & Co., Ltd., 1-1-4 Shibata, Kita-ku, Osaka, 530-0012, Japan.
Takeshi KanoGlobal Project Management Department, Shionogi & Co., Ltd., Kita-ku, Osaka, Japan.
Toshihiro WajimaClinical Research Department, Shionogi & Co., Ltd., 1-1-4 Shibata, Kita-ku, Osaka, 530-0012, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe aim of this study was to develop a population pharmacokinetic (PK)/pharmacodynamic (PD) model for describing plasma lusutrombopag concentrations and platelet response following oral lusutrombopag dosing and for evaluating covariates in the PK/PD profiles.

methodsA population PK/PD model was developed using a total of 2539 plasma lusutrombopag concentration data and 1408 platelet count data from 78 healthy adult subjects following oral single and multiple (14-day once-daily) dosing. Covariates in PK and PK/PD models were explored for subject age, body weight, sex, and ethnicity.

resultsA three-compartment model with first-order rate and lag time for absorption was selected as a PK model. A three-transit and one-platelet compartment model with a sigmoid E

conclusionA population PK/PD model was developed for lusutrombopag and shown to provide good prediction for the PK/PD profiles. The model could be used as a basic PK/PD model in the drug development of lusutrombopag.

Indexed as

AdultAge FactorsArea Under CurveBody WeightCinnamatesDose-Response Relationship, DrugDouble-Blind MethodFemaleHealthy VolunteersHumansMaleMiddle AgedModels, BiologicalRacial GroupsReceptors, ThrombopoietinSex FactorsCinnamateslusutrombopagReceptors, ThrombopoietinThiazoles

Identifiers

What OpenQuestion holds

Textmetadata
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.