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Study of GLPG1837 in Subjects With Cystic Fibrosis (S1251N Mutation)

NCT02690519 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2016-10-11

No results posted yet for this study

Summary

At least 6 cystic fibrosis patients with the S1251N mutation will be treated for 4 weeks, consisting of two consecutive treatment periods of two weeks 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

one GLPG1837 tablet in the morning and one GLPG1837 tablet in the evening, for 2 weeks

DRUG

GLPG1837 dose 2

one GLPG1837 tablet in the morning and one GLPG1837 tablet in the evening, for 2 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
2016-01-31
Primary Completion
2016-08-31
Completion
2016-09-30

Countries

  • Belgium
  • Netherlands

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 NCT02690519 on ClinicalTrials.gov