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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
GLPG2451 oral suspension, daily.
GLPG2451 oral suspension, daily.
GLPG2222 tablet for oral use, daily.
Study Site BEL004
Antwerp, Belgium
Study Site BEL003
Brussels, Belgium
Study Site BEL002
Number of subjects with adverse events.
To assess safety and tolerability of doses of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I and Part II).
Time frame: Up to 24 weeks after the last dose
Maximum observed plasma concentration (Cmax).
To characterize the pharmacokinetics (PK) of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I).
Time frame: Day 14
Maximum observed plasma concentration (Cmax).
To characterize the PK of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I).
Time frame: Day 28
Area under the plasma concentration-time curve from time zero until 24 hours (AUC0-24h).
To characterize the PK of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I).
Time frame: Day 14
Area under the plasma concentration-time curve from time zero until 24 hours (AUC0-24h).
To characterize the PK of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I).
Time frame: Day 28
Trough plasma concentration observed at the end of the dosing interval (24 hours post-dose) (Ctrough).
To characterize the PK of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I and Part II).
Time frame: Between Day 2 and Day 28
Change from baseline in sweat chloride concentration.
To assess changes in sweat chloride concentration after administration of the combination of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part II).
Time frame: Between Day 1 pre-dose and Day 28
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GLPG2737 capsules for oral use, daily.
Ghent, Belgium
Study Site BEL001
Leuven, Belgium
Study Site BGR001
Sofia, Bulgaria
Study Site DEU001
Berlin, Germany
Study Site DEU002
Essen, Germany
Study Site GRC001
Thessaloniki, Greece
Study Site NLD002
Amsterdam, Netherlands
Study Site NLD001
Utrecht, Netherlands
...and 10 more locations
Change from baseline in percent predicted FEV1.
To assess changes in percent predicted FEV1 after administration of the combination of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part II).
Time frame: Between Day 1 pre-dose and Day 28
Change from baseline in sweat chloride concentration.
To assess changes in sweat chloride concentration after administration of the combination of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I).
Time frame: Between Day 1 pre-dose and Day 28
Change from baseline in percent predicted FEV1.
To assess changes in percent predicted FEV1 after administration of the combination of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I).
Time frame: Between Day 1 pre-dose and Day 28