Evidence map›Paper›PMID 34415561›Full record

Trial reportEuropean journal of drug metabolism and pharmacokinetics2021

Pharmacokinetics, Tolerability, and Safety of Single and Multiple Omecamtiv Mecarbil Doses in Healthy Japanese and Caucasian Subjects.

Ashit Trivedi, Fady I Malik, Mia Mackowski, Shauna Hutton, Makoto Aoki, Siddique Abbasi, Sandeep Dutta, Edward Lee

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of drug metabolism and pharmacokinetics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 47% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Trial
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

8 authors at 2 institutions in 1 country.

Ashit TrivediAmgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA, 91320, USA. ashitt@amgen.com.ORCID http://orcid.org/0000-0002-5040-5722
Fady I MalikCytokinetics, San Francisco, CA, USA.
Mia MackowskiAmgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
Shauna HuttonAmgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
Makoto AokiAmgen K. K., Tokyo, Japan.
Siddique AbbasiAmgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
Sandeep DuttaAmgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
Edward LeeAmgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
Amgen (United States) · USCytokinetics (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesOmecamtiv mecarbil (OM) is a cardiac myosin activator under development for the treatment of heart failure. The pharmacokinetics of single and multiple doses of OM were investigated in healthy Japanese subjects in two clinical studies.

methodsStudy 1 (n = 36) evaluated the bioavailability and pharmacokinetics after intravenous infusion (15 mg/h for 4 h) and an oral modified release (MR) tablet in healthy Japanese and Caucasian subjects using 25 mg single and multiple doses and 50 mg single dose. Study 2 (n = 50) evaluated the pharmacokinetics of OM with multiple oral doses of 25 mg MR tablets twice a day (BID) followed by up-titration to either 37.5 mg or 50 mg BID in healthy Japanese subjects.

resultsIn Study 1, the maximum observed plasma concentration (C

conclusionsOM showed consistent and predictable pharmacokinetics after multiple dosing in Japanese subjects.

Indexed as

Administration, OralAdultArea Under CurveAsian PeopleBiological AvailabilityFemaleHalf-LifeHealthy VolunteersHumansJapanMaleTabletsUreaomecamtiv mecarbilTabletsUrea

Identifiers

PMID34415561
OpenAlexW3196132361

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.