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History of Changes for Study: NCT03540524
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. (FALCON)
Latest version (submitted April 4, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 16, 2018 None (earliest Version on record)
2 June 5, 2018 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 August 30, 2018 Contacts/Locations and Study Status
4 September 26, 2018 Recruitment Status, Study Status, Contacts/Locations, Study Design, Eligibility and Outcome Measures
5 April 4, 2019 Recruitment Status and Study Status
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Study NCT03540524
Submitted Date:  May 16, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: GLPG2737-CL-105
Brief Title: 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. (FALCON)
Official Title: Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of the Combination of GLPG2451 and GLPG2222, With or Without GLPG2737, in Adult Subjects With Cystic Fibrosis
Secondary IDs: 2017-001067-20 [EudraCT Number]
Open or close this module Study Status
Record Verification: May 2018
Overall Status: Not yet recruiting
Study Start: May 2018
Primary Completion: April 2020 [Anticipated]
Study Completion: April 2020 [Anticipated]
First Submitted: April 27, 2018
First Submitted that
Met QC Criteria:
May 16, 2018
First Posted: May 30, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
May 16, 2018
Last Update Posted: May 30, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Galapagos NV
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief 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.
Detailed Description:
Open or close this module Conditions
Conditions: Cystic Fibrosis
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Sequential Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 24 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Cohort A - F508del homozygous
Dual combination (GLPG2451 and GLPG2222) will be administered for 14 days, followed by the triple combination (GLPG2451, GLPG2222 and GLPG2737) for 14 days, without washout in between the sequential treatment periods.( Study Part I)
Drug: GLPG2451 dose regimen A
GLPG2451 oral suspension, daily.
Drug: GLPG2222
GLPG2222 tablet for oral use, daily.
Drug: GLPG2737
GLPG2737 capsules for oral use, daily.
Experimental: Cohort B - F508del heterozygous/potentiator nonresponsive
Dual combination (GLPG2451 and GLPG2222) will be administered for 14 days, followed by the triple combination (GLPG2451, GLPG2222 and GLPG2737) for 14 days, without washout in between the sequential treatment periods. (study Part II)
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.
Experimental: Cohort C - F508del homozygous
Dual combination (GLPG2451 and GLPG2222) will be administered for 14 days, followed by the triple combination (GLPG2451, GLPG2222 and GLPG2737) for 14 days, without washout in between the sequential treatment periods. (Study Part II)
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of subjects with adverse events.
[ Time Frame: Up to 24 weeks after the last dose ]

To assess safety and tolerability of doses of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I and Part II).
2. Maximum observed plasma concentration (Cmax).
[ Time Frame: Day 14 ]

To characterize the PK of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I).
3. Maximum observed plasma concentration (Cmax).
[ Time Frame: Day 28 ]

To characterize the PK of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I).
4. Area under the plasma concentration-time curve from time zero until 24 hours (AUC0-24h).
[ Time Frame: Day 14 ]

To characterize the PK of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I).
5. Area under the plasma concentration-time curve from time zero until 24 hours (AUC0-24h).
[ Time Frame: Day 28 ]

To characterize the PK of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I).
6. Trough plasma concentration observed at the end of the dosing interval (24 hours post-dose) (Ctrough).
[ Time Frame: Between Day 2 and Day 28 ]

To characterize the PK of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I and Part II).
7. Change from baseline in sweat chloride concentration.
[ Time Frame: Between Day 1 pre-dose and Day 28 ]

To assess changes in sweat chloride concentration after administration of the combination of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part II).
8. Change from baseline in percent predicted FEV1.
[ Time Frame: Between Day 1 pre-dose and Day 28 ]

To assess changes in percent predicted FEV1 after administration of the combination of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part II).
Secondary Outcome Measures:
1. Change from baseline in sweat chloride concentration.
[ Time Frame: Between Day 1 pre-dose and Day 28 ]

To assess changes in sweat chloride concentration after administration of the combination of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I).
2. Change from baseline in percent predicted FEV1.
[ Time Frame: Between Day 1 pre-dose and Day 28 ]

To assess changes in percent predicted FEV1 after administration of the combination of GLPG2451 and GLPG2222 with or without GLPG2737 (Study Part I).
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Female or male subject ≥18 years of age, on the day of signing the ICF
  • Confirmed clinical diagnosis of CF (documented in the subject's medical record).
  • Eligible CFTR genotype at screening:
    • Cohort A: Homozygous for the F508del CFTR mutation
    • Cohort B: Heterozygous for the F508del CFTR mutation with a potentiator non-responsive mutation on the second allele
    • Cohort C: Homozygous for the F508del CFTR mutation
  • A body weight of ≥40 kg at screening.
  • Stable concomitant medication for pulmonary health for CF for at least 4 weeks prior to the first study drug administration and planned continuation of the same concomitant medication for the duration of the dosing period of the study. Subjects with diabetes mellitus and/or pancreatic insufficiency are eligible for the study provided they are on stable treatment (e.g. medication, diet, pancreatic enzyme replacement therapy) for at least 4 weeks prior to the first study drug administration in the opinion of the investigator.
  • Forced expiratory volume in 1 second (FEV1): 40% ≤ FEV1 ≤ 90% of predicted normal for age, sex, and height at screening (pre- or post bronchodilator) at screening.
  • Sweat chloride concentration ≥60 mmol/L at screening.
  • Non-smoker and non-user of any nicotine and or cannabis containing products. A non-smoker is defined as an individual who has abstained from smoking for at least 1 year prior to the screening. A non-user is defined as an individual who has abstained from any nicotine containing products for at least 1 year prior to the screening.

Exclusion Criteria:

  • History of or ongoing allergic bronchopulmonary aspergillosis.
  • Medical history of cataract (or lens opacity) and/or glaucoma.
  • Cataract (or lens opacity) and/or glaucoma determined by an ophthalmologist during the screening period.
  • Unstable pulmonary status or respiratory tract infection (including rhinosinusitis) requiring a change in therapy within 4 weeks prior to the first study drug administration.
  • History of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator.
  • Need for supplemental oxygen during the day, and >2 L/minute while sleeping.
  • History of hepatic cirrhosis with portal hypertension (e.g., signs/symptoms of splenomegaly, esophageal varices).
  • History of malignancy within the past 5 years (except for basal cell carcinoma of the skin with no evidence of recurrence and/or carcinoma in situ of the cervix that has been treated with no evidence of recurrence).
  • Use of any moderate and strong inhibitor(s) or inducer(s) of CYP3A4 within 4 weeks prior to the first study drug administration (e.g., clarithromycin, itraconazole, ketoconazole, telithromycin, rifampin, carbamazepine).
  • Use of CFTR modulator therapy (e.g., lumacaftor and/or ivacaftor) within 4 weeks prior to the first study drug administration.
  • Use of any oral corticosteroid within 3 months of screening; or history of oral corticosteroid use for ≥30 days (cumulative) within 2 years of screening.
  • Abnormal liver function test at screening; defined as AST and/or ALT and/or alkaline phosphatase and/or gamma-glutamyl transferase (GGT) ≥3× the upper limit of normal (ULN); and/or total bilirubin ≥1.5× the ULN.
Open or close this module Contacts/Locations
Central Contact Person: Evelyn Fox
Telephone: 0032 15 34 29 00
Email: evelyn.fox@glpg.com
Study Officials: Olivier Van de Steen, MD MBA
Study Director
Galapagos NV
Locations: Belgium
Study Site BEL004
Antwerp, Belgium
Study Site BEL003
Brussels, Belgium
Study Site BEL002
Gent, Belgium
Study Site BEL001
Leuven, Belgium
Bulgaria
Study Site BGR001
Sofia, Bulgaria
Germany
Study Site DEU001
Berlin, Germany
Study Site DEU002
Essen, Germany
Greece
Study Site GRC001
ThessalonĂ­ki, Greece
Netherlands
Study Site NLD002
Amsterdam, Netherlands
Study Site NLD001
Utrecht, Netherlands
Serbia
Study Site SRB001
Belgrade, Serbia
Sweden
Study Site SWE001
Göteborg, Sweden
Study Site SWE002
Stockholm, Sweden
United Kingdom
Study Site GBR003
Birmingham, United Kingdom
Study Site GBR004
Glasgow, United Kingdom
Study Site GBR005
Liverpool, United Kingdom
Study Site GBR001
Papworth Everard, United Kingdom
Study Site GBR002
Wythenshawe, United Kingdom
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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