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
Phase of Trial: Phase I
Latest Information Update: 29 Jan 2019
At a glance
- Drugs PTI-801 Proteostasis Therapeutics (Primary)
- Indications Cystic fibrosis
- Focus Adverse reactions; Pharmacokinetics
- Sponsors Proteostasis Therapeutics
- 17 Jan 2019 Planned number of patients changed from 125 to 180.
- 17 Jan 2019 Planned End Date changed from 1 Aug 2018 to 1 Jun 2019.
- 17 Jan 2019 Planned primary completion date changed from 1 Aug 2018 to 1 Jun 2019.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History