Study Assessing PTI-428 Safety, Tolerability, and Pharmacokinetics in Subjects With Cystic Fibrosis on KALYDECO® as Background Therapy

Details

Therapeutic category
Restore CFTR Function
Trial status
Completed Participating Centres
Phase
Phase I

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.

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
102997
Trial type
Medication
Length of participation
21 weeks
Intervention
CFTR Modulator
Recruitment target
16
Last edited date
16/03/2018
CF sponsor
Proteostasis Therapeutics, Inc.
CF sponsor type
Commercial

Who can take part?

Age
18+
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.

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