Evidence map›Paper›PMID 22526314›Full record

Trial reportAntimicrobial agents and chemotherapy2012

Pharmacokinetic comparison of a single oral dose of polymorph form i versus form V capsules of the antiorthopoxvirus compound ST-246 in human volunteers.

Jarasvech Chinsangaram, Kady M Honeychurch, Shanthakumar R Tyavanagimatt, Tove' C Bolken, Robert Jordan, Kevin F Jones, Thomas Marbury, Israel Lichtenstein, Margaret Pickens, Michael Corrado and 4 more

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

Trial report in Antimicrobial agents and chemotherapy, 2012. 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
0.8field-weighted citation impact, top 30% 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, 19 citations in OpenAlex.

  1. Article
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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

14 authors at 3 institutions in 1 country.

Jarasvech ChinsangaramSIGA Technologies, Corvallis, Oregon, USA.
Kady M Honeychurch
Shanthakumar R Tyavanagimatt
Tove' C Bolken
Robert Jordan
Kevin F Jones
Thomas Marbury
Israel Lichtenstein
Margaret Pickens
Michael Corrado
Patrick Landis
Jean M Clarke
Annie M Frimm
Dennis E Hruby
Siga Technologies (United States) · USINC Research (United States) · USOrlando Clinical Research Center · US

Funding

NIAID NIH HHS HHSN266200600014C
6 · The paper itself

Abstract

ST-246, a novel compound that inhibits egress of orthopoxvirus from mammalian cells, is being tested as a treatment for pathogenic orthopoxvirus infections in humans. This phase I, double-blind, randomized, crossover, exploratory study was conducted to compare the pharmacokinetics (PK) of a single daily 400-mg oral dose of ST-246 polymorph form I versus polymorph form V administered to fed, healthy human volunteers. Both forms appeared to be well tolerated, with no serious adverse events. The order of administration of the two forms had no effect on the results of the PK analyses. Form I and form V both exhibited comparable plasma concentration versus time profiles, but complete bioequivalence between the two forms was not found. Maximum drug concentration (C(max)) met the bioequivalence criteria, as the 90% confidence interval (CI) was 80.6 to 96.9%. However, the area under the concentration-time curve from time zero to time t (AUC(0-t)) and AUC(0-∞) did not meet the bioequivalence criteria (CIs of 67.8 to 91.0% and 73.9 to 104.7%, respectively). The extent of absorption of form I, as defined by AUC(0-∞), was 11.7% lower than that of form V. Since ST-246 form I is more thermostable than form V, form I was selected for further development and use in all future studies.

Indexed as

Administration, OralAdolescentAdultAntiviral AgentsBenzamidesCapsulesDouble-Blind MethodFemaleHumansIsoindolesMaleMiddle AgedOrthopoxvirusPhthalimidesYoung AdultAntiviral AgentsBenzamidesCapsulesIsoindolesPhthalimidestecovirimat

Identifiers

PMID22526314
PMCPMC3393399
OpenAlexW2089500834

What OpenQuestion holds

Textmetadata
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.