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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03540524 on ClinicalTrials.gov