Evidence map›Paper›PMID 35279815›Full record

ArticleDrugs in R&D2022

A Phase I, Open-label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of AMG 986 in Healthy Japanese Subjects.

Ashit Trivedi, Omar Mather, Silvia Vega, Shauna Hutton, Jennifer Hellawell, Edward Lee

Abstract read
In one paragraph

Article in Drugs in R&D, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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

6 citing papers in PubMed.

  1. Review
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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

6 authors.

Ashit TrivediAmgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA, USA. ashitt@amgen.com.ORCID http://orcid.org/0000-0002-5040-5722
Omar MatherAmgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA, USA.
Silvia VegaAmgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA, USA.
Shauna HuttonAmgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA, USA.
Jennifer HellawellAmgen Inc., San Francisco, CA, USA.
Edward LeeAmgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveAMG 986 is a first-in-class, novel apelin receptor small molecule agonist initially developed as a treatment for patients with heart failure (HF). Previously, a first-in-human study of AMG 986 was conducted in healthy and HF subjects; however, AMG 986 was not evaluated in Japanese subjects.

methodsThis was a phase I, open-label, single-dose, single-center study conducted to evaluate the safety and pharmacokinetics (PK) of AMG 986 200 mg and 400 mg in 12 healthy Japanese subjects. Six subjects received AMG 986 200 mg and six subjects received AMG 986 400 mg.

resultsFollowing oral administration, median time to maximum observed plasma concentration (t

conclusionAMG 986 exposure increased with increasing dose, and the increase was less than dose proportional in healthy Japanese subjects. The results of this study could facilitate the subsequent clinical development of AMG 986 for the treatment of Japanese patients with HF.

Indexed as

Healthy VolunteersAdministration, OralArea Under CurveDose-Response Relationship, DrugHumansJapan

Identifiers

PMID35279815
PMCPMC9167390

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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.