A study of FDL169 in subjects with Cystic Fibrosis

Details

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

Full title

A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of FDL169 in Cystic Fibrosis Subjects Homozygous for the F508del-CFTR mutation

This is a randomized, placebo controlled, double-blinded study. 24 CF subjects will be assigned randomly to two groups, active drug or placebo. Three doses of FDL169 or placebo will be given 3 times a day for 28 days. The aim of this clinical study is to test how well CF subjects tolerate FDL169. In addition, the study will also test how subjects’ bodies absorb and digest FDL169 by measuring study subjects’ blood at specific intervals after taking the tablet orally.
Trial Reference Number
90508
Trial type
Medication
Length of participation
28 days
Intervention
CFTR Modulator
Recruitment target
24
Last edited date
05/07/2019
CF sponsor
Flatley Discovery Lab LLC
CF sponsor type
Commercial

Who can take part?

Age
18+
Top inclusion criteria
  • Homozygous for F508del mutation
  • Weight ≥40 kg
  • Age 18 years or older
  • Ability to perform a valid, reproducible spirometry test
Top exclusion criteria
  • An acute upper or lower respiratory tract infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks prior to Day 1.
  • Major complications of lung disease (including massive hemoptysis, pneumothorax, or pleural effusion) within 8 weeks prior to screening.
  • Impaired renal function or known portal hypertension.

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