Study of GLPG1837 in Subjects With Cystic Fibrosis (G551D Mutation)
NCT ID: NCT02707562
Last Updated: 2016-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
26 participants
INTERVENTIONAL
2016-02-29
2016-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GLPG1837 dose 1, GLPG1837 dose 2, GLPG1837 dose 3
GLPG1837 twice daily oral dosing - morning and evening, for 4 weeks
GLPG1837 dose 1
two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for one week
GLPG1837 dose 2
two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for one week
GLPG1837 dose 3
two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for two weeks
Interventions
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GLPG1837 dose 1
two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for one week
GLPG1837 dose 2
two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for one week
GLPG1837 dose 3
two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for two weeks
Eligibility Criteria
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Inclusion Criteria
* Subjects with gating G551D CFTR mutation on at least one allele in the CFTR gene
* Subjects currently receiving treatment with ivacaftor on a stable regimen or not on a treatment regimen with ivacaftor, for at least 2 weeks prior to screening
* Weight ≥ 40.0 kg
* Subjects on stable concomitant treatment regimen for at least 4 weeks prior to baseline (excluding ivacaftor)
* Pre- or post-bronchodilator FEV1 ≥ 40% of predicted normal
* Subject will have to use highly effective contraceptive methods
Exclusion Criteria
* Concomitant use of antifungal drugs within 4 weeks of baseline
* A history of a clinically meaningful unstable or uncontrolled chronic disease
* Liver cirrhosis and portal hypertension
* Any significant change in the medical regimen for pulmonary health within 4 weeks of baseline
* Unstable pulmonary status or respiratory tract infection or changes in therapy for pulmonary disease within 4 weeks of baseline
* Abnormal liver function
* Clinically significant abnormalities on ECG
* History of malignancy, solid organ/haematological transplantation
* Abnormal renal function
* Participation in another experimental therapy study within 30 days or 5 times halflife
18 Years
ALL
No
Sponsors
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Galapagos NV
INDUSTRY
Responsible Party
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Principal Investigators
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Olivier Van de Steen, MD, MBA
Role: STUDY_DIRECTOR
Galapagos NV
Locations
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Royal Adelaide Hospital
Adelaide, , Australia
The Prince Charles Hospital
Chermside, , Australia
Monash Medical Centre
Clayton, , Australia
Sir Charles Gairdner Hospital
Nedlands, , Australia
Mater Adult Hospital
South Brisbane, , Australia
Fakultni nemocnice v Motole
Prague, , Czechia
Charité Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinkikum Koeln
Cologne, , Germany
Uniklinik Carl-Gustav-Carus
Dresden, , Germany
Lungenheilkunde München-Pasing
München, , Germany
Beamont Hospital
Dublin, , Ireland
St. Vincent's University Hospital
Dublin, , Ireland
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
The Medicines Evaluation Unit Ltd
Manchester, , United Kingdom
Countries
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References
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Davies JC, Van de Steen O, van Koningsbruggen-Rietschel S, Drevinek P, Derichs N, McKone EF, Kanters D, Allamassey L, Namour F, de Kock H, Conrath K. GLPG1837, a CFTR potentiator, in p.Gly551Asp (G551D)-CF patients: An open-label, single-arm, phase 2a study (SAPHIRA1). J Cyst Fibros. 2019 Sep;18(5):693-699. doi: 10.1016/j.jcf.2019.05.006. Epub 2019 May 27.
Other Identifiers
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2015-003291-77
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GLPG1837-CL-201
Identifier Type: -
Identifier Source: org_study_id