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: 09 Aug 2017

At a glance

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

    • 04 Aug 2017 Part two has been added to the trial,number of arms changed from 5 to 9 ,hence patient number has also changed from 60 to120.
    • 04 Aug 2017 Planned End Date changed from 25 Jul 2017 to 1 Jul 2018.
    • 04 Aug 2017 Planned primary completion date changed from 25 Jul 2017 to 1 Apr 2018.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top