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.

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