Evidence map›Paper›PMID 32274653›Full record

Trial reportClinical drug investigation2020

Pharmacokinetics, Pharmacodynamics, and Safety of Peficitinib (ASP015K) in Healthy Male Caucasian and Japanese Subjects.

Mai Shibata, Toshifumi Hatta, Masako Saito, Junko Toyoshima, Yuichiro Kaneko, Kazuo Oda, Tetsuya Nishimura

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

Trial report in Clinical drug investigation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01225224 (Phase I Study of ASP015K), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 34% 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.

NCT01225224 phase1completednot on this map

Phase I Study of ASP015K: Single-Dose and Multiple-Dose Oral Administration in Healthy Nonelderly Men

TypeinterventionalSponsorAstellas Pharma IncRan2009 to 2010Enrolled72ConditionsPharmacokinetics of ASP015K, Healthy VolunteerArmspeficitinib, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. 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

7 authors at 2 institutions in 2 countries.

Mai ShibataAstellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo, 103-8411, Japan. mai.shibata@astellas.com.ORCID http://orcid.org/0000-0001-5370-662X
Toshifumi HattaAstellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo, 103-8411, Japan.
Masako SaitoAstellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo, 103-8411, Japan.
Junko ToyoshimaAstellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo, 103-8411, Japan.
Yuichiro KanekoAstellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo, 103-8411, Japan.
Kazuo OdaAstellas Research Institute of America LLC, 1 Astellas Way, Northbrook, IL, 60062, USA.
Tetsuya NishimuraAstellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo, 103-8411, Japan.
Astellas Pharma (Japan) · JPAstellas Pharma (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivePeficitinib pharmacokinetics and pharmacodynamics have been characterized mainly in Caucasian subjects. This study investigated the pharmacokinetics, pharmacodynamics, safety, and tolerability of peficitinib in healthy Japanese subjects compared with Caucasian subjects.

methodsIn this single-center, randomized, double-blind, placebo-controlled study, a cohort of healthy Japanese (n = 24) and Caucasian (n = 24) men received a single oral dose of peficitinib (20, 60, or 200 mg) or placebo. Another cohort of Japanese men (n = 24) received peficitinib (10, 30, or 100 mg) or placebo twice daily for 7 days. Pharmacokinetic and pharmacodynamic parameters were assessed, and adverse events (AEs) monitored throughout.

resultsDose proportionality of maximum plasma drug concentration (C

conclusionsPeficitinib was well tolerated at doses up to 200 mg daily for 7 days in healthy Japanese subjects. Dose-proportional exposure was demonstrated across the single-dose range of 20-200 mg, with greater peficitinib exposure in Japanese compared with Caucasian subjects. The pharmacokinetic/pharmacodynamic relationships were considered comparable between these populations. CLINICALTRIALS. GOV IDENTIFIER: NCT01225224.

Indexed as

Asian PeopleWhite PeopleAdamantaneAdultArea Under CurveDouble-Blind MethodHealth StatusHealthy VolunteersHumansJapanMaleMiddle AgedNiacinamidePlacebosYoung AdultAdamantaneNiacinamidepeficitinibPlacebos

Identifiers

PMID32274653
PMCPMC7181426
OpenAlexW3015520765

What OpenQuestion holds

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LicenceCC BY-NC
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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.