Study Assessing PTI-428 Safety, Tolerability, and Pharmacokinetics in Subjects With Cystic Fibrosis on KALYDECO® as Background Therapy
- Therapeutic category
- Restore CFTR Function
- Trial status
- Completed Participating Centres
- Phase I
A Phase I, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects With Cystic Fibrosis.The single treatment group will enroll adult subjects with CF currently on stable KALYDECO® background therapy for a minimum of 3 months at the time of randomization. Subjects will be randomized to either PTI-428 or placebo. Each dose will be administered once daily (QD) for a total of 14 Days. The subjects will continue treatment with KALYDECO® throughout the study.
- Trial Reference Number
- Trial type
- Length of participation
- 21 weeks
- CFTR Modulator
- Recruitment target
- Last edited date
- CF sponsor
- Proteostasis Therapeutics, Inc.
- CF sponsor type
Who can take part?
- Top inclusion criteria
- Stable on Kalydeco dosing for minimum of 3 months prior to study
- Non-smoker and non-tobacco user for a minimum of 30 days prior to screening
- Top exclusion criteria
- Participation in another clinical trial or treatment with an investigational agent within 30 days.
- History of organ transplantation.