Evidence map›Paper›PMID 20385870›Full record

Trial reportAntimicrobial agents and chemotherapy2010

Safety and pharmacokinetics of the antiorthopoxvirus compound ST-246 following repeat oral dosing in healthy adult subjects.

Robert Jordan, Jarasvech Chinsangaram, Tove' C Bolken, Shanthakumar R Tyavanagimatt, Deborah Tien, Kevin F Jones, Annie Frimm, Michael L Corrado, Margaret Pickens, Patrick Landis and 3 more

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

Trial report in Antimicrobial agents and chemotherapy, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed
1.6field-weighted citation impact, top 18% 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

31 citing papers in PubMed, 53 citations in OpenAlex.

  1. Trial
  2. Oral Tecovirimat for the Treatment of Smallpox.The New England journal of medicine · 2018
    Trial
  3. Trial
  4. Review
  5. Review
  6. Review
  7. Mpox: what sexual health physicians need to know?International journal of impotence research · 2024
    Review
  8. Review
  9. Antivirals With Activity Against Mpox: A Clinically Oriented Review.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Review
  10. Review
  11. Monkeypox in humans: a new outbreak.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2022
    Review
  12. Antiviral Treatment against Monkeypox: A Scoping Review.Tropical medicine and infectious disease · 2022
    Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Inpatient Management of Monkeypox.The Brown journal of hospital medicine · 2022
    Review
  18. Review
  19. Article
  20. 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

13 authors at 3 institutions in 1 country.

Robert JordanSIGA Technologies, Inc., Corvallis, OR 97333, USA.
Jarasvech Chinsangaram
Tove' C Bolken
Shanthakumar R Tyavanagimatt
Deborah Tien
Kevin F Jones
Annie Frimm
Michael L Corrado
Margaret Pickens
Patrick Landis
Jean Clarke
Thomas C Marbury
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 infected cells, is being evaluated as a treatment for pathogenic orthopoxvirus infections in humans. This phase I, double-blind, randomized, placebo-controlled, escalating multiple-dose study was conducted to determine the safety, tolerability, and pharmacokinetics of ST-246 administered as a single daily oral dose of 250, 400, or 800 mg for 21 days to nonfasting healthy human volunteers. ST-246 appeared to be well tolerated, with no serious adverse events (AEs). Headache, for which one subject in the 800-mg group discontinued the study, was the most commonly reported AE in all treatment groups. The multiple-dose pharmacokinetics of ST-246 was well characterized. The day 21 mean elimination half-lives were calculated at 18.8, 19.8, and 20.7 h for each of the 250-, 400-, and 800-mg/day dose groups, respectively. Steady state was reached by day 6 (within 3 to 5 half-lives), saturable absorption was observed at the 800-mg dose level, and the fraction of parent drug excreted in the urine was very low. Based on these results, administration of 400 mg/day ST-246 can be expected to provide plasma concentrations above the efficacious concentration demonstrated in nonhuman primate models in earlier studies.

Indexed as

Administration, OralAdolescentAdultAntiviral AgentsBenzamidesDouble-Blind MethodFemaleHalf-LifeHumansIsoindolesMaleMiddle AgedOrthopoxvirusPhthalimidesPoxviridae InfectionsYoung AdultAntiviral AgentsBenzamidesIsoindolesPhthalimidestecovirimat

Identifiers

PMID20385870
PMCPMC2876426
OpenAlexW2110922235

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.