Safety, Tolerability, and Pharmacokinetics of PTI-808, PTI-801, and PTI-428 Combination Therapy in Subjects With Cystic Fibrosis

Details

Therapeutic category
Restore CFTR Function
Trial status
Completed Participating Centres

Full title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study Designed to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808-02, and PTI-428 Combination Therapy in Subjects With Cystic Fibrosis

The study is a randomized, double-blind, placebo-controlled, study that will be conducted at multiple centers in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation.
Trial Reference Number
108654
Trial type
Medication
Intervention
CFTR Modulators
Last edited date
28/01/2019
CF sponsor
Proteostasis Therapeutics, Inc.
CF sponsor type
Commercial

Who can take part?

Age
18+
Top inclusion criteria
  • Homozygous for F508del mutation
  • Forced expiratory volume in 1 second (FEV1) 40-90% predicted, inclusive.
  • Non-smoker and non-tobacco user for a minimum of 30 days prior to screening
Top exclusion criteria
  • Currently taking or has taken a CFTR modulator within 30 days prior to initial dose of study drugs
  • Participation in another clinical trial or treatment with an investigational agent within 28 days of Day 1
  • History of organ transplantation.

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