Evidence map›Paper›PMID 33650758›Full record

Trial reportClinical and translational science2021

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Dose and Multiple-Rising-Dose Study of the BTK Inhibitor TAK-020 in Healthy Subjects.

Ehsanollah Esfandiari, Mary Chen, Glennda Smithson, Derek Blair, Helene Faessel, John Wagner, Lachy Mclean, Eric R Fedyk

Open access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.7field-weighted citation impact, top 31% 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

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. The Development of BTK Inhibitors: A Five-Year Update.Molecules (Basel, Switzerland) · 2021
    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

8 authors at 1 institution in 2 countries.

Ehsanollah EsfandiariTakeda Pharmaceuticals International Inc., Cambridge, Massachusetts, USA.
Mary ChenTakeda Pharmaceuticals International Inc., Cambridge, Massachusetts, USA.
Glennda SmithsonTakeda Pharmaceuticals International Inc., Cambridge, Massachusetts, USA.
Derek BlairTakeda Pharmaceuticals International Inc., Cambridge, Massachusetts, USA.
Helene FaesselTakeda Pharmaceuticals International Inc., Cambridge, Massachusetts, USA.
John WagnerTakeda Pharmaceuticals International Inc., Cambridge, Massachusetts, USA.
Lachy McleanTakeda Pharmaceuticals International Inc., Cambridge, Massachusetts, USA.
Eric R FedykTakeda Pharmaceuticals International Inc., Cambridge, Massachusetts, USA.ORCID 0000-0002-5503-7172
Takeda (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Bruton's tyrosine kinase (BTK) is a target for treatment of hematologic malignancies and autoimmune diseases. TAK-020 is a highly selective covalent BTK inhibitor that inhibits both B cell receptor and fragment crystallizable receptor signaling. We assessed the safety/tolerability and pharmacokinetics/pharmacodynamics (PDs) of TAK-020 in healthy subjects. Each cohort of the single-rising dose (n = 72; 9 cohorts) and the multiple-rising dose (n = 48; 6 cohorts) portions of the study comprised six TAK-020-treated and two placebo-treated, subjects aged 18-55 years (inclusive). The PD effects were assessed by measuring BTK occupancy and the inhibition of fragment crystallizable epsilon receptor 1 (FcεRI)-mediated activation of basophils. Overall, treatment-emergent adverse events (TEAEs) were similar to placebo; there were no serious TEAEs or no TEAEs leading to discontinuation. TAK-020 was rapidly absorbed (median time to maximum plasma concentration (T

Indexed as

Administration, OralAdolescentAdultAgammaglobulinaemia Tyrosine KinaseBasophilsDose-Response Relationship, DrugDouble-Blind MethodFemaleHealthy VolunteersHumansMaleMiddle AgedMyasthenia GravisPlacebosProtein Kinase InhibitorsPurpura, Thrombocytopenic, IdiopathicAgammaglobulinaemia Tyrosine KinaseBTK protein, humanPlacebosProtein Kinase Inhibitors

Identifiers

PMID33650758
PMCPMC8212709
OpenAlexW3135073908

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.