Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: GLPG1690 600 mg QD; Placebo QD
Intervention description: GLPG1690 capsules, administered at a dose of 600 mg, orally QD; Matching placebo capsules, administered orally QD
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Idiopathic Pulmonary Fibrosis; GLPG1690; Autotaxin

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).
    

Eligibility 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