Trial intelligence / Profile preview

Safety, PK, and DDI of PTI-801 in Healthy Volunteers and CF Patients

NCT03140527Phase 1Completed

Sponsor
Proteostasis Therapeutics
Start
Apr 2017
Primary completion
Feb 2020
Modality
Small Molecules
Countries
5
01

Overview

Phase 1, randomised, double-blind trial of Posenacaftor in cystic fibrosis (CF) (13 arms), sponsored by Proteostasis Therapeutics. Primary endpoints: Safety and tolerability measured by adverse events, labs, ECGs, physical exams, vital signs at 21 days, Apparent terminal half-life at 72 hours and 5 more. Started Apr 2017; status: completed.

02

Drugs

Posenacaftor
03

Conditions

cystic fibrosis (CF)

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