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A Phase 1, Randomised, Open-Label, Crossover Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of PBI-4050 Compared to Sodium Phenylbutyrate in Healthy Subjects

Trial Profile

A Phase 1, Randomised, Open-Label, Crossover Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of PBI-4050 Compared to Sodium Phenylbutyrate in Healthy Subjects

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 04 Aug 2022

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At a glance

  • Drugs Fezagepras (Primary) ; Sodium phenylbutyrate
  • Indications Hyperammonaemia
  • Focus Adverse reactions
  • Sponsors Liminal BioSciences

Most Recent Events

  • 21 Jul 2022 According to Liminal BioSciences media release, the company has discontinued development of fezagepras based on results from this trial, which indicated fezagepras was significantly inferior compared to Sodium Phenylbutyrate as a nitrogen scavenger. The recommendation to stop the development program for fezagepras was not based on safety concerns.
  • 21 Jul 2022 Status changed from recruiting to discontinued, according to a Liminal BioSciences media release.
  • 23 May 2022 Status changed from not yet recruiting to recruiting as per Liminal BioSciences media release

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