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Safety, tolerability and pharmacokinetics of emodepside, a potential novel treatment for onchocerciasis (river blindness), in healthy male subjects.

Jean-Yves GillonJeremy M T J DennisonFrans van den BergSophie DelhommeKaren Dequatre CheesemanClaudia Peña RossiNathalie Strub-WourgaftSabine SpechtBelén PedriqueFrédéric MonnotSusanne SkrabsMaria-Luisa RodriguezHeino Stass
Published in: British journal of clinical pharmacology (2021)
Overall, emodepside had acceptable safety and tolerability profiles, no major safety concerns, after single oral administration of 20 mg as LSF and after multiple oral administration over 10 days at 5 and 10 mg OD and at 10 mg twice daily. For further clinical trials, the development of a tablet formulation overcoming the limitations observed in the present study with the IR tablet formulation is considered.
Keyphrases
  • clinical trial
  • open label
  • drug delivery
  • randomized controlled trial
  • risk assessment
  • double blind
  • combination therapy
  • study protocol
  • human health