PTI-428
Sponsors
University Medical Center Utrecht, Proteostasis Therapeutics, Inc.
Conditions
Cystic FibrosisCystic Fibrosis - CompleteHealthy VolunteerHealthy Volunteer - Complete
Phase 1
Study Assessing PTI-428 Safety, Tolerability, and Pharmacokinetics in Subjects With Cystic Fibrosis
CompletedNCT02718495
Start: 2016-07-19End: 2017-11-28Updated: 2019-03-21
Study to Assess the Safety, Tolerability, PK, ECG Effects, Food Effect, and Drug-drug Interaction (DDI) of Hormonal Contraceptives of PTI-428 in Healthy Female Volunteers
CompletedNCT02846142
Start: 2016-06-30End: 2017-03-31Updated: 2018-05-24
Study Designed to Assess the Safety, Tolerability and PK of PTI-808 in Healthy Volunteers and in Adults With Cystic Fibrosis
CompletedNCT03251092
Start: 2017-07-17End: 2019-12-23Updated: 2020-04-22
Study Assessing PTI-428 Safety, Tolerability, and Pharmacokinetics in Subjects With Cystic Fibrosis on KALYDECO® as Background Therapy
CompletedNCT03258424
Start: 2017-07-28End: 2018-10-03Updated: 2020-03-26
Safety, Tolerability, and Pharmacokinetics of PTI-808, PTI-801, and PTI-428 Combination Therapy in Subjects With Cystic Fibrosis
CompletedNCT03500263
Start: 2018-01-30End: 2019-03-13Updated: 2020-04-06
Phase 2
Study Assessing PTI-428 Safety, Tolerability, Pharmacokinetics and Effect in Subjects With Cystic Fibrosis
CompletedNCT03591094
Start: 2018-08-21End: 2019-02-18Updated: 2020-02-27
A Phase IIb, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Dirocaftor/Posenacaftor/Nesolicaftor in Subjects with Cystic Fibrosis Aged 18 Years or Older (CHOICES)
CompletedCTIS2022-500410-26-01
Start: 2024-05-27End: 2025-05-28Target: 48Updated: 2025-06-02