Evidence map›Paper›PMID 35586186›Full record

Trial reportDrug design, development and therapy2022

Pharmacokinetics and Safety of Single and Multiple Doses of Peficitinib (ASP015K) in Healthy Chinese Subjects.

Xin Gao, Xuemei He, Hiroyuki Oshima, Daisuke Miyatake, Yukio Otsuka, Kota Kato, Chunxiao Cai, Tomasz Wojtkowski, Nan Song, Yuichiro Kaneko and 1 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04143477 (An Open-Label, Single and Multiple Dose Study to Evaluate the Pharmacokinetics and Safety of ASP015K in Healthy Chinese Subjects), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 35% 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.

NCT04143477 phase1completednot on this map

An Open-Label, Single and Multiple Dose Study to Evaluate the Pharmacokinetics and Safety of ASP015K in Healthy Chinese Subjects

TypeinterventionalSponsorAstellas Pharma China, Inc.Ran2019 to 2020Enrolled36ConditionsHealthy VolunteersArmspeficitinib
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. 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

11 authors at 5 institutions in 3 countries.

Xin GaoClinical Trial Center, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.
Xuemei HeClinical Trial Center, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.
Hiroyuki OshimaClinical Pharmacology and Exploratory Development, Astellas Pharma Inc., Tokyo, Japan.
Daisuke MiyatakeClinical Pharmacology and Exploratory Development, Astellas Pharma Inc., Tokyo, Japan.
Yukio OtsukaClinical Pharmacology and Exploratory Development, Astellas Pharma Inc., Tokyo, Japan.
Kota KatoAnalysis & Pharmacokinetics Research Labs., Astellas Pharma Inc., Ibaraki, Japan.
Chunxiao CaiDevelopment Medical Department, Astellas (China) Investment Co., Ltd, Beijing, People's Republic of China.
Tomasz WojtkowskiData Science Development, Astellas Pharma US, Inc., Northbrook, IL, USA.
Nan SongDevelopment Division Biostatistics and Statistical Programming, Astellas (China) Investment Co., Ltd, Beijing, People's Republic of China.
Yuichiro KanekoBiostatistics Group, Japan-Asia Data Science, Development, Astellas Pharma Inc, Tokyo, Japan.
Aixin ShiClinical Trial Center, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.
Astellas Pharma (Japan) · JPAstellas Pharma (China) · CNBeijing Hospital · CNAstellas Pharma (United States) · USChinese Academy of Medical Sciences & Peking Union Medical College · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: To investigate the pharmacokinetics and safety of peficitinib (Janus kinase inhibitor for the treatment of rheumatoid arthritis) in healthy Chinese subjects following single and multiple doses. Methods: This open-label, randomized study was conducted at one site in China. Subjects received peficitinib 50, 100 or 150 mg as a single dose on Day 1 (fasted) and once daily from Days 8 to 13 in the multiple-dose period (fed). Blood samples were collected before administration each day, and up to 72h post administration. Pharmacokinetic assessments included area under the concentration curve (AUC), half-life (t Results: Thirty-six subjects were enrolled (12 per dose group). After a single dose of peficitinib, median t Conclusion: Following single and multiple doses of peficitinib in healthy Chinese subjects, peficitinib demonstrated rapid absorption and was well tolerated at all doses. Clinicaltrialsgov Identifier: NCT04143477.

Indexed as

AdamantaneJanus Kinase InhibitorsAdministration, OralArea Under CurveDose-Response Relationship, DrugHealthy VolunteersHumansNiacinamideAdamantaneJanus Kinase InhibitorsNiacinamidepeficitinibdose-proportionalityrheumatoid arthritistreatmenttsDMARDs

Identifiers

PMID35586186
PMCPMC9109889
OpenAlexW4229366186

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.