Evidence map›Paper›PMID 29582248›Full record

Trial reportClinical drug investigation2018

Safety and Pharmacokinetics of DS-8500a, a Novel GPR119 Agonist, After Multiple Oral Doses in Healthy Japanese Males.

Manabu Kato, Hidetoshi Furuie, Emi Kamiyama, Kazuhito Shiosakai, Kazutaka Yoshihara, Takashi Taguchi

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

Trial report in Clinical drug investigation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.1field-weighted citation impact, top 21% 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

5 citing papers in PubMed, 11 citations in OpenAlex.

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

6 authors at 1 institution in 1 country.

Manabu KatoClinical Pharmacology Department, Daiichi Sankyo Co., Ltd, 1-2-58 Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan. kato.manabu.w4@daiichisankyo.co.jp.
Hidetoshi FuruieOsaka Pharmacology Clinical Research Hospital, 4-1-29 Miyahara, Yodogawa-ku, Osaka, 532-0003, Japan.
Emi KamiyamaClinical Pharmacology Department, Daiichi Sankyo Co., Ltd, 1-2-58 Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan.
Kazuhito ShiosakaiBiostatistics & Data Management, Daiichi Sankyo Co., Ltd, 1-2-58 Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan.
Kazutaka YoshiharaClinical Pharmacology Department, Daiichi Sankyo Co., Ltd, 1-2-58 Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan.
Takashi TaguchiClinical Development Department, Daiichi Sankyo Co., Ltd, 1-2-58 Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan.
Daiichi-Sankyo (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesG protein-coupled receptor 119 (GPR119) agonists reduce plasma glucose by promoting insulin secretion in a glucose-dependent manner. We evaluated the safety and pharmacokinetics of multiple oral doses of DS-8500a, a GPR119 agonist, under fed conditions in healthy adult Japanese male subjects.

methodsIn this Phase 1, randomized, placebo-controlled, double-blind, multiple oral dose study, participants were aged ≥ 20 and ≤ 45 years with a body mass index ≥ 18.5 and < 25.0 kg/m

resultsTwenty-four subjects were included (6, 9, and 9 in the placebo, 50-, and 100-mg groups, respectively). On Day 7, the mean maximum plasma concentration (C

conclusionsDS-8500a plasma concentrations reached steady state from Day 3, and C STUDY REGISTRY IDENTIFICATION: JAPIC ID: JapicCTI-173550 (registered retrospectively on 30 March 2017).

Indexed as

Administration, OralAdultArea Under CurveDose-Response Relationship, DrugDouble-Blind MethodHumansMaleReceptors, G-Protein-CoupledYoung AdultGPR119 protein, humanReceptors, G-Protein-Coupled

Identifiers

PMID29582248
OpenAlexW2796292943

What OpenQuestion holds

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Registered trials

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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.