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A Phase 1b, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, 2-Period Crossover Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Oral Administration of BMN 255 in Participants With Non-Alcoholic Fatty Liver Disease (NAFLD) And Hyperoxaluria

Trial Profile

A Phase 1b, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, 2-Period Crossover Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Oral Administration of BMN 255 in Participants With Non-Alcoholic Fatty Liver Disease (NAFLD) And Hyperoxaluria

Status: Withdrawn prior to enrolment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

Latest Information Update: 14 Jun 2024

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At a glance

  • Drugs BMN 255 (Primary)
  • Indications Hyperoxaluria; Non-alcoholic fatty liver disease
  • Focus Adverse reactions
  • Sponsors BioMarin Pharmaceutical

Most Recent Events

  • 10 Jun 2024 Planned End Date changed from 1 Oct 2024 to 25 Mar 2024.
  • 10 Jun 2024 Planned primary completion date changed from 31 Jul 2024 to 25 Mar 2024.
  • 10 Jun 2024 Status changed from recruiting to withdrawn prior to enrolment. (Reason the study was stopped: The study was withdrawn because BioMarin decided to end the overall development program. The study withdrawal was not due to any patient safety concerns.)

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