GLPG2737-CL-105 Assessment of multiple oral doses of GLPG2451/GLPG2222
Details
- Therapeutic category
- Restore CFTR Function
- Trial status
- Completed Participating Centres
- Phase
- Phase I
Full title
Assessment of safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of the combination of GLPG2451 and GLPG2222, with or without GLPG2737, in adult subjects with cystic fibrosis
This is a Phase Ib, multi-center, open-label, nonrandomized multiple cohorts study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of a combination treatment of GLPG2451 and GLPG2222, with and without GLPG2737, in adult subjects with Cystic Fibrosis.- Trial Reference Number
- 104923
- Trial type
- Medication
- Intervention
- CFTR Modulators
- Recruitment target
- 24
- Last edited date
- 20/12/2017
- CF sponsor
- Galapagos
- CF sponsor type
- Commercial
Who can take part?
- Age
- 18+
- Top inclusion criteria
- Homozygous or Heterozygous (with non-responsive mutation on 2nd allele) for F508del mutation
- Sweat chloride concentration ≥60 mmol/L at screening.
- A body weight of ≥40 kg at screening.
- Top exclusion criteria
- Medical history of cataract (or lens opacity) and/or glaucoma.