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: 09 Aug 2017
At a glance
- Drugs PTI-801 Proteostasis Therapeutics (Primary)
- Indications Cystic fibrosis
- Focus Adverse reactions; Pharmacokinetics
- Sponsors Proteostasis Therapeutics
- 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.