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Clinical pharmacology study of BBI608 - A randomized, double blind, placebo controlled single-oral dose ascending study in healthy male and female Japanese volunteers to investigate the tolerability, safety, pharmacokinetics, QT/QTc assessment of BBI608. - A randomized, double blind, single-oral dose study in healthy Japanese male volunteers to examine the effect of food with sequential design. - An open-label single-oral dose study in healthy non-Asian male volunteers to evaluate pharmacokinetics

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Trial Profile

Clinical pharmacology study of BBI608 - A randomized, double blind, placebo controlled single-oral dose ascending study in healthy male and female Japanese volunteers to investigate the tolerability, safety, pharmacokinetics, QT/QTc assessment of BBI608. - A randomized, double blind, single-oral dose study in healthy Japanese male volunteers to examine the effect of food with sequential design. - An open-label single-oral dose study in healthy non-Asian male volunteers to evaluate pharmacokinetics

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 14 Dec 2021

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At a glance

  • Drugs Napabucasin (Primary)
  • Indications Colorectal cancer; Gastric cancer; Gastrointestinal cancer; Glioblastoma; Haematological malignancies; Liver cancer; Mesothelioma; Non-small cell lung cancer; Oesophageal cancer; Pancreatic cancer; Solid tumours
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Sumitomo Dainippon Pharma

    • Most Recent Events

    • 01 Mar 2021 New trial record
    • 17 Jan 2021 Results assessing food effects on napabucasin pharmacokinetics in two studies JapicCTI-205447; NCT01775423, presented at the 2021 Gastrointestinal Cancers Symposium.

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