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Trial record 1 of 5 for:    GLPG1837
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Study of GLPG1837 in Subjects With Cystic Fibrosis (S1251N Mutation) (SAPHIRA2)

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ClinicalTrials.gov Identifier: NCT02690519
Recruitment Status : Completed
First Posted : February 24, 2016
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Tracking Information
First Submitted Date  ICMJE February 16, 2016
First Posted Date  ICMJE February 24, 2016
Last Update Posted Date October 11, 2016
Study Start Date  ICMJE January 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2016)
  • Changes in adverse events [ Time Frame: Up to 9 weeks ]
    To evaluate the safety and tolerability of GLPG1837 in terms of adverse events at every visit
  • Changes in laboratory parameters [ Time Frame: Up to 7 weeks ]
    To evaluate the safety and tolerability of GLPG1837 in terms of abnormal laboratory parameters at every visit
  • Changes in vital signs [ Time Frame: Up to 9 weeks ]
    To evaluate the safety and tolerability of GLPG1837 in terms of abnormal vital signs at every visit
  • Changes in physical examination [ Time Frame: Up to 9 weeks ]
    To evaluate the safety and tolerability of GLPG1837 in terms of abnormal physical examination at every visit
  • Changes in electrocardiogram [ Time Frame: Up to 7 weeks ]
    To evaluate the safety and tolerability of GLPG1837 in terms of abnormal electrocardiogram at every visit
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2016)
  • Changes in sweat chloride concentration [ Time Frame: Up to 9 weeks ]
    To evaluate the effect of GLPG1837 in terms of change in sweat chloride concentration, a biomarker to measure cystic fibrosis transmembrane conductance regulator (CFTR) ion channel function at every visit
  • Changes in pulmonary function (forced expiratory volume in 1 second, FEV1) assessed by spirometry [ Time Frame: Up to 9 weeks ]
    To explore the effect of GLPG1837 in terms of change in pulmonary function (forced expiratory volume in 1 second, FEV1) assessed by spirometry at every visit
  • Plasma levels of GLPG1837 [ Time Frame: Up to 4 weeks ]
    To characterize the pharmacokinetics (PK) of GLPG1837 by measuring the amount in plasma between Day 1 and Day 29 at every visit
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of GLPG1837 in Subjects With Cystic Fibrosis (S1251N Mutation)
Official Title  ICMJE A Phase IIa, Open-label Study of Two Doses of GLPG1837 in Subjects With Cystic Fibrosis and the S1251N Mutation
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: GLPG1837 dose 1 and GLPG1837 dose 2
GLPG1837 twice daily oral dosing - morning and evening, for 4 weeks
Interventions:
  • Drug: GLPG1837 dose 1
  • Drug: GLPG1837 dose 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2016)
7
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2016)
6
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects ≥ 18 years of age, with a confirmed diagnosis of cystic fibrosis
  • Subjects with gating S1251N 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:

  • On an ivacaftor-containing treatment regimen and unable or unwilling to discontinue ivacaftor for the washout and treatment periods of the study
  • 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 half-life
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02690519
Other Study ID Numbers  ICMJE GLPG1837-CL-202
2015-003292-30 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galapagos NV
Study Sponsor  ICMJE Galapagos NV
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Olivier Van de Steen, MD, MBA Galapagos NV
PRS Account Galapagos NV
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP