A study of FDL169 in subjects with Cystic Fibrosis
Details
- Therapeutic approach
- Restore CFTR Function
- Trial status
- Closed with results Participating Centres
- Trials Tracker ID
- TT001716
- Last updated
- 05/07/2019
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
Study detailsThis 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.
- Phase
- Phase 1
- Length of participation
- 28 days
- Recruitment target
- 24
- CF sponsor
- Flatley Discovery Lab LLC
- CF sponsor type
- Commercial
Who can take part?
- Age range
- 18 years and older
- Including people
Homozygous for F508del mutation
Weight ≥40 kg
Age 18 years or older
Ability to perform a valid, reproducible spirometry test- Excluding people
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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