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Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690

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ClinicalTrials.gov Identifier: NCT02738801
Recruitment Status : Completed
First Posted : April 14, 2016
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

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, PK and 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, week 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/BALF samples, Spirometry, St George's respiratory questionnaire, high-resolution computed tomography (HRCT).

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: GLPG1690 group 1 Drug: Placebo group 2 Phase 2

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


Arm Intervention/treatment
Experimental: GLPG1690 group 1 Drug: GLPG1690 group 1
600 mg GLPG1690 q.d., administered as oral capsules

Placebo Comparator: group 2 Drug: Placebo group 2
Oral capsules matching those of GLPG1690 group 1




Primary Outcome Measures :
  1. Difference versus placebo in the number of subjects with adverse events [ Time Frame: Up to the Follow Up visit 2 weeks after the last study drug administration (anticipated to be week 14) ]
    to evaluate safety and tolerability of GLPG1690

  2. Difference versus placebo in the number of subjects with abnormal lab values [ Time Frame: Up to the Follow Up visit 2 weeks after the last study drug administration (anticipated to be week 14) ]
    to evaluate safety and tolerability of GLPG1690

  3. Difference versus placebo in the number of subjects with abnormal vital signs [ Time Frame: Up to the Follow Up visit 2 weeks after the last study drug administration (anticipated to be week 14) ]
    to evaluate safety and tolerability of GLPG1690

  4. Difference versus placebo in the number of subjects with abnormal ECG [ Time Frame: Up to the Follow Up visit 2 weeks after the last study drug administration (anticipated to be week 14) ]
    to evaluate safety and tolerability of GLPG1690

  5. Difference versus placebo in the number of subjects with abnormal Physical examination [ Time Frame: Up to the Follow Up visit 2 weeks after the last study drug administration (anticipated to be week 14) ]
    to evaluate safety and tolerability of GLPG1690

  6. The maximum observed plasma concentration of GLPG1690 [ Time Frame: Up to the follow up visit 2 weeks after the last study drug administration (anticipated to be week 14) ]
    to characterize the PK properties of GLPG1690

  7. The time at which maximum observed plasma concentration of GLPG1690 is reached [ Time Frame: Up to the follow up visit 2 weeks after the last study drug administration (anticipated to be week 14) ]
    to characterize the PK properties of GLPG1690

  8. The area under the plasma drug concentration-time curve of a dosing interval [ Time Frame: Up to the follow up visit 2 weeks after the last study drug administration (anticipated to be week 14) ]
    to characterize the PK properties of GLPG1690

  9. trough plasma concentration (just before the next dosing) [ Time Frame: Up to the follow up visit 2 weeks after the last study drug administration (anticipated to be week 14) ]
    to characterize the PK properties of GLPG1690

  10. Concentration in blood/BALF of LPA (lysophosphatidic acid) [ Time Frame: Up to the follow up visit 2 weeks after the last study drug administration (anticipated to be week 14) ]
    Pharmacodynamic parameter


Secondary Outcome Measures :
  1. Changes in pulmonary function assessed by spirometry [ Time Frame: Up to the follow up visit 2 weeks after the last study drug administration (anticipated to be week 14) ]
  2. Changes in biomarkers in blood and BALF [ Time Frame: Up to week 12 ]
  3. Change in HRCT images [ Time Frame: Up to 12 weeks ]
    To explore the effect of GLPG1690 on functional respiratory imaging parameters derived from HRCT at baseline and week 12

  4. Changes in quality of life measures [ Time Frame: Up to the Follow Up visit 2 weeks after the last study drug administration (anticipated to be week 14) ]
    To explore the effect of GLPG1690 on the Saint George Respiratory Questionnaire or measure of quality of life through 12 weeks



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 IRB/IEC approved 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. 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 clinical significant abnormalities on ECG
  5. Subjects with IPF exacerbation within 6 weeks prior to screening
  6. Subjects with a lower respiratory tract infection requiring antibiotics with 4 weeks pre screening
  7. Smoking within 3 months pre-screening
  8. interstitial lung disease
  9. history of lung volume reduction surgery of lung transplant
  10. unstable cardiac or pulmonary disease other than IPF within 6 months pre-screening
  11. subjects with abnormal liver function
  12. subjects with abnormal renal function

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
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
Study Director: Ann Fieuw, MD Galapagos NV

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT02738801     History of Changes
Other Study ID Numbers: GLPG1690-CL-202
2015-004157-41 ( EudraCT Number )
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial