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Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02738801
Recruitment Status : Completed
First Posted : April 14, 2016
Results First Posted : November 6, 2020
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Study Description
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Brief Summary:
A multicenter randomized, double-blind, parallel group, placebo-controlled, exploratory phase IIa study in subjects with Idiopathic Pulmonary Fibrosis (IPF) to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GLPG1690. Male and female subjects aged 40 years or older will be screened to determine eligibility. The screening period will be up to 4 weeks. At baseline, eligible subjects will be randomized in a 3:1 ratio to GLPG1690 or matching placebo administered for 12 weeks. The subjects will visit the study center at screening, baseline, Weeks 1, 2, 4, 8 and 12 and for a follow-up visit 2 weeks after the last administration of study drug. Planned assessments: Adverse event reporting, clinical laboratory tests, vital signs, physical examination, 12-Lead-ECG, PK blood sampling, biomarker blood/bronchoalveolar lavage fluid (BALF), Spirometry, St George's respiratory questionnaire, high-resolution computed tomography (HRCT).

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: GLPG1690 600 mg QD Drug: Placebo QD Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Study Start Date : March 2016
Actual Primary Completion Date : May 2, 2017
Actual Study Completion Date : May 2, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: GLPG1690 600 mg once daily (QD) Drug: GLPG1690 600 mg QD
GLPG1690 capsules, administered at a dose of 600 mg, orally QD
Placebo Comparator: Placebo QD Drug: Placebo QD
Matching placebo capsules, administered orally QD


Outcome Measures
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Primary Outcome Measures :
  1. Number of Patients With Treatment-Emergent Adverse Events (AEs) [ Time Frame: From screening up to Day 98 ]
  2. Mean Maximum Observed Plasma Concentration (Cmax; Micrograms Per Milliliter [µg/mL]) of GLPG1690 [ Time Frame: Baseline, predose on Days 7, 14, 28, 56, 84, and 98 (or at early discontinuation), and at 1.5, 4, and 6 hours postdose on Day 28 ]
  3. Median Time to Occurrence of GLPG1690 Cmax (Tmax; Hours [h]) [ Time Frame: Baseline, predose on Days 7, 14, 28, 56, 84, and 98 (or at early discontinuation), and at 1.5, 4, and 6 hours postdose on Day 28 ]
  4. Mean Area Under the Plasma Concentration-Time Curve (AUC[t]; µg.h/mL) of GLPG1690 [ Time Frame: Baseline, predose on Days 7, 14, 28, 56, 84, and 98 (or at early discontinuation), and at 1.5, 4, and 6 hours postdose on Day 28 ]
  5. Mean GLPG1690 Plasma Concentration Observed at Predose (Ctrough; µg/mL) [ Time Frame: Baseline, predose on Days 7, 14, 28, 56, 84, and 98 (or at early discontinuation), and at 1.5, 4, and 6 hours postdose on Day 28 ]
  6. Mean Peak Area Ratio of Lysophosphatidic Acid (LPA) C18:2 Species in Blood [ Time Frame: Baseline (Day -1), predose and 1.5 and 6 hours postdose on Day 28, predose on Day 84, and Day 98 (or early discontinuation) ]
    LPA species C18:2 concentrations were determined in blood using a validated liquid chromatography tandem mass spectometry (LC/MS-MS) method. The baseline reference timepoint was Day -1 (mean of the pre-dosing duplicates).

  7. Mean Peak Area Ratio of LPA C18:2 Species in Bronchoalveolar Lavage Fluid (BALF) [ Time Frame: Baseline (Day -1) and Day 84 ]
    LPA species C18:2 concentrations were determined in BALF using a validated LC/MS-MS method. The baseline reference timepoint was Day -1 (mean of the pre-dosing duplicates).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects able and willing to sign the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF)
  2. Male or female subjects of non-child-bearing potential aged ≥ 40 years
  3. Subjects with a chest HRCT performed within 12 months prior to screening
  4. Subjects with IPF diagnosed by a multidisciplinary team
  5. Subjects with: a. forced vital capacity (FVC) ≥50% predicted of normal AND b. Diffusing capacity for the lungs for carbon monoxide (DLCO) ≥ 30% predicted of normal corrected for hemoglobin
  6. Subjects with a forced expiratory volume in 1 second (FEV1)/FVC (Tiffeneau-Pinelli index) ratio ≥ 0.70 (based on pre-bronchodilator spirometry
  7. Subjects on stable supportive care
  8. Subjects in stable condition

Exclusion Criteria:

  1. Subjects with know hypersensitivity to any of the study drug ingredients
  2. Subjects with a history of or current immunosuppressive condition
  3. Subjects with a history of malignancy within the past 5 years
  4. Subjects with clinically significant abnormalities on ECG
  5. Subjects with acute IPF exacerbation within 6 weeks prior to screening
  6. Subjects with a lower respiratory tract infection requiring antibiotics with 4 weeks prior to screening
  7. Smoking within 3 months pre-screening
  8. Interstitial lung disease
  9. History of lung volume reduction surgery or lung transplant
  10. Unstable cardiac or pulmonary disease other than IPF within 6 months prior to screening
  11. Subjects with abnormal liver function
  12. Subjects with abnormal renal function
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738801


Locations
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Ukraine
Municipal Clinical Hospital # 6
Dnipropetrovsk, Ukraine
Kharkov City Clinical Hospital # 13
Kharkov, Ukraine
F.G. Yanovskyy Institute of Phthisiatry and Pulmonology 1
Kiev, Ukraine
F.G. Yanovskyy Institute of Phthisiatry and Pulmonology 2
Kiev, Ukraine
Oesa Regional Clinical Hospital
Odesa, Ukraine
Poltava Regional Clinical Antituberculosis Dispancery
Poltava, Ukraine
United Kingdom
Royal Brompton Hospital
London, United Kingdom
The Medicines Evaluation Unit
Manchester, United Kingdom
Sponsors and Collaborators
Galapagos NV
Investigators
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Study Director: Ann Fieuw, MD Galapagos NV
  Study Documents (Full-Text)

Documents provided by Galapagos NV:
Study Protocol  [PDF] October 16, 2015
Statistical Analysis Plan  [PDF] June 16, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT02738801    
Other Study ID Numbers: GLPG1690-CL-202
2015-004157-41 ( EudraCT Number )
First Posted: April 14, 2016    Key Record Dates
Results First Posted: November 6, 2020
Last Update Posted: November 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Galapagos NV:
Idiopathic Pulmonary Fibrosis
GLPG1690
Autotaxin
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases