Evidence map›Paper›PMID 28799823›Full record

Trial reportNucleic acid therapeutics2017

Lack of QT Prolongation for 2'-O-Methoxyethyl-Modified Antisense Oligonucleotides Based on Retrospective Exposure/Response Analysis of Ten Phase 1 Dose-Escalation Placebo-Controlled Studies in Healthy Subjects.

Rosie Z Yu, Rudy Gunawan, Richard S Geary, Steven G Hughes, Scott P Henry, Yanfeng Wang

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Nucleic acid therapeutics, 2017. 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. Trial
  2. Trial
  3. Article
  4. Article
  5. Targeting RNA: A Transformative Therapeutic Strategy.Clinical and translational science · 2019
    Review
  6. 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.

Rosie Z Yu1 Department of Pharmacokinetics and Clinical Pharmacology, Ionis Pharmaceuticals, Inc. , Carlsbad, California.
Rudy Gunawan1 Department of Pharmacokinetics and Clinical Pharmacology, Ionis Pharmaceuticals, Inc. , Carlsbad, California.
Richard S Geary2 Department of Clinical Development, Ionis Pharmaceuticals, Inc. , Carlsbad, California.
Steven G Hughes2 Department of Clinical Development, Ionis Pharmaceuticals, Inc. , Carlsbad, California.
Scott P Henry3 Department of Nonclinical Development, Ionis Pharmaceuticals, Inc. , Carlsbad, California.
Yanfeng Wang1 Department of Pharmacokinetics and Clinical Pharmacology, Ionis Pharmaceuticals, Inc. , Carlsbad, California.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The potential of QT prolongation of ten 2'-O-methoxyethyl-modified (2'-MOE) antisense oligonucleotides (ASOs) was evaluated retrospectively via exposure/response (ER) analysis using data from Phase 1 clinical studies in healthy subjects. All Phase 1 studies were double-blind, placebo-controlled, single and multiple ascending dose studies designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of the ASOs in healthy subjects. The active doses in these studies ranged from 50 to 450 mg administered by subcutaneous (SC) injection in single and multiple ascending dose cohorts. Two of the ten studies also included 2-h intravenous (IV) infusions up to 600 mg. Electrocardiogram (ECG) measurements were performed at baseline and selected time points (including T

Indexed as

ElectrocardiographyAdultCohort StudiesCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodFemaleHealthy VolunteersHumansMaleOligonucleotides, AntisenseRetrospective StudiesOligonucleotides, AntisenseantisenseoligonucleotideQT prolongation

Identifiers

PMID28799823
PMCPMC5649121

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.