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Study of GLPG1837 in Subjects With Cystic Fibrosis (G551D Mutation)

NCT02707562 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2016-12-07

No results posted yet for this study

Summary

32 cystic fibrosis patients with the G551D mutation will be treated for 4 weeks, consisting of three consecutive treatment periods: two 1-week periods followed by one 2-week period, evaluating one dose of GLPG1837 each. After the treatment period, there is a 7-10 days follow-up period.

During the course of the study, subjects will be examined for any side effects that may occur (safety and tolerability).

Changes in sweat chloride will be assessed as biomarker from baseline onwards, and changes in pulmonary function (efficacy) will be explored throughout the study. The amount of GLPG1837 present in the blood (pharmacokinetics) will also be determined.

Conditions

Interventions

DRUG

GLPG1837 dose 1

two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for one week

DRUG

GLPG1837 dose 2

two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for one week

DRUG

GLPG1837 dose 3

two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for two weeks

Sponsors & Collaborators

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Olivier Van de Steen, MD, MBA · Galapagos NV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Australia
  • Czechia
  • Germany
  • Ireland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT02707562 on ClinicalTrials.gov