Evidence map›Paper›PMID 33314790›Full record

Trial reportCPT: pharmacometrics & systems pharmacology2021

Concentration-QTc Modeling of Ozanimod's Major Active Metabolites in Adult Healthy Subjects.

Emily Briggs, Sunny Chapel, Peijin Zhang, Maria Palmisano, Jonathan Q Tran

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

Trial report in CPT: pharmacometrics & systems pharmacology, 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
0.1field-weighted citation impact, top 48% 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, 5 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

5 authors at 2 institutions in 2 countries.

Emily BriggsAnn Arbor Pharmacometrics Group, Ann Arbor, Michigan, USA.
Sunny ChapelAnn Arbor Pharmacometrics Group, Ann Arbor, Michigan, USA.
Peijin ZhangClinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol Myers Squibb Company, Princeton, New Jersey, USA.
Maria PalmisanoClinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol Myers Squibb Company, Princeton, New Jersey, USA.
Jonathan Q TranClinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol Myers Squibb Company, Princeton, New Jersey, USA.
Bristol-Myers Squibb (Germany) · DEBristol-Myers Squibb (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ozanimod, approved by regulatory agencies in multiple countries for the treatment of adults with relapsing multiple sclerosis, is a sphingosine 1-phosphate (S1P) receptor modulator, which binds with high affinity selectively to S1P receptor subtypes 1 and 5. The relationships between plasma concentrations of ozanimod and its major active metabolites, CC112273 and CC1084037, and the QTc interval (C-QTc) from a phase I multiple-dose study in healthy subjects were analyzed using nonlinear mixed effects modeling. QTc was modeled linearly as the sum of a sex-related fixed effect, baseline, and concentration-related random effects that incorporated interindividual and residual variability. Common linear, power, and maximum effect (E

Indexed as

Administration, OralAdultCase-Control StudiesDouble-Blind MethodElectrocardiographyFemaleHealthy VolunteersHeart RateHumansIndansLong QT SyndromeMaleMultiple Sclerosis, Relapsing-RemittingOxadiazolesPlacebosPredictive Value of TestsIndansOxadiazolesozanimodPlacebosSphingosine 1 Phosphate Receptor ModulatorsSphingosine-1-Phosphate Receptors

Identifiers

PMID33314790
PMCPMC7894403
OpenAlexW3112197865

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.