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.
NCT03540524 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2019-04-08
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
Interventions
- 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.
Sponsors & Collaborators
-
Galapagos NV
lead INDUSTRY
Principal Investigators
-
Olivier Van de Steen, MD MBA · Galapagos NV
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-31
- Primary Completion
- 2019-03-11
- Completion
- 2019-03-11
Countries
- Belgium
- Bulgaria
- Germany
- Greece
- Netherlands
- Serbia
- Sweden
- United Kingdom
Study Locations
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