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The Effect of Hepatic Impairment on the Pharmacokinetics of Balovaptan: A Phase I, Multiple-Center, Open-Label Study Following Multiple Daily Oral Doses of Balovaptan in Subjects With Moderate Hepatic Impairment and Healthy Subjects With Normal Hepatic Function

Trial Profile

The Effect of Hepatic Impairment on the Pharmacokinetics of Balovaptan: A Phase I, Multiple-Center, Open-Label Study Following Multiple Daily Oral Doses of Balovaptan in Subjects With Moderate Hepatic Impairment and Healthy Subjects With Normal Hepatic Function

Status: Withdrawn prior to enrolment
Phase of Trial: Phase I

Latest Information Update: 01 Nov 2021

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At a glance

  • Drugs Balovaptan (Primary)
  • Indications Pervasive child development disorders
  • Focus Pharmacokinetics
  • Sponsors Roche

Most Recent Events

  • 26 Oct 2021 Status changed from suspended to withdrawn prior to enrolment.
  • 16 Apr 2021 Status changed from not yet recruiting to suspended due to stopping of the Autism Spectrum Disorder program with balovatpan, the study drug
  • 13 Aug 2020 Planned End Date changed from 13 Oct 2020 to 13 Oct 2022.

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