NCT03540524

A Study Looking at the Safety, Tolerability and Efficacy of the Combination of the Study Drugs GLPG2451 and GLPG2222 With or Without GLPG2737 in Patients With Cystic Fibrosis.

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	GLPG2451 dose regimen A	GLPG2451 oral suspension, daily.
DRUG	GLPG2451 dose regimen B	GLPG2451 oral suspension, daily.
DRUG	GLPG2222	GLPG2222 tablet for oral use, daily.
DRUG	GLPG2737	GLPG2737 capsules for oral use, daily.

Timeline

• Start date: 2018-05-31
• Primary completion: 2019-03-11
• Completion: 2019-03-11
• First posted: 2018-05-30
• Last updated: 2019-04-08

Locations

20 sites across 8 countries: Belgium, Bulgaria, Germany, Greece, Netherlands, Serbia, Sweden, United Kingdom