Study Assessing PTI-428 Safety, Tolerability, and Pharmacokinetics in Subjects With Cystic Fibrosis
Status:
Completed
Trial end date:
2017-11-28
Target enrollment:
Participant gender:
Summary
This trial will consist of three arms: Part A, Part B, and Part C. Part A has two groups. The
first group will enroll adult subjects with cystic fibrosis (CF) into a single ascending dose
(SAD) treatment group. The second group will enroll adult subjects with CF, including those
on background treatment with ORKAMBI® and those not on a cystic fibrosis transmembrane
conductance regulator (CFTR) modulator, into a multiple ascending dose (MAD) treatment group.
Part B will enroll adult subjects with CF currently on stable ORKAMBI® background therapy for
a minimum of 3 months into a Phase II treatment group consisting of two cohorts. Part C will
enroll adult subjects with CF, including those on background treatment with KALYDECO® and
those not on a CFTR modulator, into a Phase II treatment group consisting of three cohorts.
Approximately 136 subjects will be enrolled.