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A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI 808 in Healthy Adult Subjects and in Adults With Cystic Fibrosis

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Trial Profile

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI 808 in Healthy Adult Subjects and in Adults With Cystic Fibrosis

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Dirocaftor (Primary) ; Nesolicaftor; Posenacaftor
  • Indications Cystic fibrosis
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Proteostasis Therapeutics

    • Most Recent Events

    • 20 Apr 2020 Status changed from active, no longer recruiting to completed.
    • 09 Jan 2020 Status changed from recruiting to active, no longer recruiting.
    • 14 Jun 2019 Phase changed from 1 to 1/2, Number of arm changed form 12 to 15, Part 4 added, where CF subjects who are either homozygous for the F508del CFTR genotype or are heterozygous for the F508del CFTR genotype will be enrolled. Planned patient number changed from 135 to 180.

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