Evidence map›Paper›PMID 30117300›Full record

Trial reportClinical and translational science2018

Evaluation of the Cardiac Safety of Long-Acting Endectocide Moxidectin in a Randomized Concentration-QT Study.

Sally A Kinrade, Jay W Mason, Carlos R Sanabria, Craig R Rayner, Julie M Bullock, Stephanie H Stanworth, Mark T Sullivan

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

Trial report in Clinical and translational science, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.4field-weighted citation impact, top 19% 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

11 citing papers in PubMed, 18 citations in OpenAlex.

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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

7 authors at 4 institutions in 1 country.

Sally A KinradeMedicines Development for Global Health, Melbourne, Australia.
Jay W MasonMason Cardiac Safety Consulting, Reno, Nevada, USA.
Carlos R SanabriaSpaulding Clinical Research, LLC, West Bend, Wisconsin, USA.
Craig R RaynerCertara Strategic Consulting, Melbourne, Australia.
Julie M BullockCertara Strategic Consulting, Melbourne, Australia.
Stephanie H StanworthMason Cardiac Safety Consulting, Reno, Nevada, USA.
Mark T SullivanMedicines Development for Global Health, Melbourne, Australia.
Center for Global Development · USStrategic Solutions Consulting (United States) · USUniversity of Nevada, Reno · USSpaulding Clinical Research (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Potential effects on cardiac repolarization of single doses of moxidectin, a potent long-acting macrocyclic lactone endectocide, were assessed in a concentration-QT (c-QT; exposure-response) study. This double-blind, placebo-controlled, parallel-group study in healthy male volunteers (n = 60) randomized subjects to a single oral dose of moxidectin (4 mg, 8 mg, 16 mg, 24 mg, or 36 mg) or matching placebo. Serial plasma samples for pharmacokinetic (PK) analysis and concurrent triplicate electrocardiogram measurements were taken at baseline and 14 prespecified time points over 72 hours, yielding 900 QT interval-plasma concentration time-matched pairs. Moxidectin had no statistically significant or clinically relevant impact on QT interval at any dose level. The primary mixed effects model analysis revealed no treatment-related impact on the Fridericia-corrected QT interval-plasma concentration gradient (-0.0077, 90% confidence interval (CI) -0.0255 to +0.0101).

Indexed as

AdultAntinematodal AgentsCardiotoxicityDose-Response Relationship, DrugDouble-Blind MethodElectrocardiographyHalf-LifeHealthy VolunteersHeart RateHumansMacrolidesMaleMiddle AgedNeglected DiseasesOnchocerciasisYoung AdultAntinematodal AgentsMacrolidesmoxidectin

Identifiers

PMID30117300
PMCPMC6226119
OpenAlexW2886193439

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.