A Multi-Center, Randomized, Placebo-Controlled, Phase 1, Two-Part Study Designed to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic Fibrosis

Trial Profile

A Multi-Center, Randomized, Placebo-Controlled, Phase 1, Two-Part Study Designed to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic Fibrosis

Recruiting
Phase of Trial: Phase I

Latest Information Update: 11 Dec 2017

At a glance

  • Drugs PTI-801 Proteostasis Therapeutics (Primary)
  • Indications Cystic fibrosis
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Proteostasis Therapeutics
  • Most Recent Events

    • 11 Dec 2017 According to a Proteostasis Therapeutics media release, the first cohort of up to 20 patients is still recruiting with enrollment expected to complete in Q1 2018.
    • 11 Dec 2017 Initial results (n = 5) presented in a Proteostasis Therapeutics media release.
    • 14 Nov 2017 According to a Proteostasis Therapeutics media release, the Company is conducting a 14-day study of PTI-801 and is currently enrolling and dosing CF patients on Orkambi background therapy. Proteostasis expects to report initial data from this study in the fourth quarter of 2017.
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