Study to Assess Safety Tolerability Pharmacokinetic and Pharmacodynamic Properties of GLPG1690

  • STATUS
    Recruiting
  • participants needed
    24
  • sponsor
    Galapagos NV
Updated on 11 November 2020
Imperial College Healthcare NHS Trust, Hammersmith Hospital (5.9 mi away) Contact
ct scan
carbon monoxide
bronchodilator
spirometry
idiopathic pulmonary fibrosis
glpg1690

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).

Details
Treatment GLPG1690 group 1, Placebo group 2
Clinical Study IdentifierNCT02738801
SponsorGalapagos NV
Last Modified on11 November 2020

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