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An Open Label Study of the Pharmacokinetics of Intravenous and Oral Amisulpride in Adults With Severe Renal Impairment and Healthy Control Subjects

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Trial Profile

An Open Label Study of the Pharmacokinetics of Intravenous and Oral Amisulpride in Adults With Severe Renal Impairment and Healthy Control Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 14 Dec 2021

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At a glance

  • Drugs Amisulpride (Primary) ; Amisulpride (Primary)
  • Indications Chemotherapy-induced nausea and vomiting; Postoperative nausea and vomiting
  • Focus Pharmacokinetics; Registrational
  • Sponsors Acacia Pharma

    • Most Recent Events

    • 13 Dec 2021 According to an Acacia Pharma media release, the company plans to publish the results of the study in a peer-reviewed journal during 2022. The results will support amendment of the BARHEMSYS label to include use in patients with severe renal impairment.
    • 13 Dec 2021 According to an Acacia Pharma media release, this clinical trial was required by the US Food and Drug Administration (FDA) as part of the February 2020 approval of BARHEMSYS for the prevention and treatment of postoperative nausea and vomiting (PONV).
    • 13 Dec 2021 Results presented in an Acacia Pharma media release.

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