Study Assessing PTI-428 Safety, Tolerability, and Pharmacokinetics in Subjects With Cystic Fibrosis on KALYDECO® as Background Therapy
Details
- Therapeutic approach
- Restore CFTR Function
- Trial status
- Closed with results Participating Centres
- Trials Tracker ID
- TT001826
- Last updated
- 16/03/2018
Full title
A Phase I, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects With Cystic Fibrosis.
Study detailsThe 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.
- Phase
- Phase 1
- Length of participation
- 21 weeks
- Recruitment target
- 16
- CF sponsor
- Proteostasis Therapeutics, Inc.
- CF sponsor type
- Commercial
Who can take part?
- Age range
- 18+
- Including people
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- Excluding people
Participation in another clinical trial or treatment with an investigational agent within 30 days.
History of organ transplantation.
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