CLINICAL TRIALS PROFILE FOR GLPG1690
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Clinical Trials for GLPG1690
Trial ID | Title | Status | Sponsor | Phase | Summary |
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NCT02179502 ↗ | First-in-Human Single and Multiple Dose of GLPG1690 | Completed | Galapagos NV | Phase 1 | The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1690 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1690 given to healthy male subjects daily for 14 days compared to placebo, will be evaluated. Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1690 present in the blood and urine (pharmacokinetics) as well as the reduction of biomarker levels by GLPG1690 in plasma samples (pharmacodynamics) will be characterized compared to placebo. The pharmacokinetics of a solid dosage formulation of GLPG1690 will be compared with those of a liquid dosage formulation of GLPG1690. Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1690 will be explored. |
NCT02738801 ↗ | Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | Completed | Galapagos NV | Phase 2 | 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). |
NCT03143712 ↗ | Study to Assess Bioavailability of GLPG1690 Given as Oral Capsule or Tablet | Completed | Galapagos NV | Phase 1 | This study is a Phase I, randomized, open-label, cross-over study with three single-dose treatments to compare the bioavailability of an oral tablet relative to an oral capsule of GLPG1690 after single dose intake in healthy male subjects and to evaluate the effect of food on the bioavailability of the oral tablet. |
NCT03515382 ↗ | A Study in Healthy Male Volunteers to Look at How the Test Medicine GLPG1690 is Taken up by the Body When Doses of Itraconazole and Voriconazole Are Given to Healthy Volunteers | Completed | Galapagos NV | Phase 1 | The sponsor wants to investigate how well the test medicine is taken up by the body when given alongside two other already approved medicines. This kind of study is known as a drug-drug interaction study. In this case the other medicines are itraconazole and voriconazole. The sponsor will also look at the safety and tolerability of the test medicine when taken alone, and when taken with the approved medicines. |
NCT03711162 ↗ | A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care | Terminated | Galapagos NV | Phase 3 | The main purpose of this study is to see how GLPG1690 works together with your current standard treatment on your lung function and IPF disease in general. The study will also investigate how well GLPG1690 is tolerated (for example if you get any side effects while on study drug). |
NCT03733444 ↗ | A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care | Terminated | Galapagos NV | Phase 3 | The main purpose of this study is to see how GLPG1690 works together with the current standard treatment on your lung function and IPF disease in general. The study will also investigate how well GLPG1690 is tolerated (for example if you get any side effects while on study drug). |
NCT03787186 ↗ | A Study in Healthy Male Volunteers to Look at How the Test Medicine GLPG1690 is Taken up by the Body When Given by Mouth and Into a Vein as an Injection | Completed | Galapagos NV | Phase 1 | The sponsor wants to investigate how well the test medicine is taken up by the body when given orally (by mouth) as a tablet or capsule and as a solution for infusion (into a vein). The capsule and the solution will be radiolabelled. 'Radiolabelled' means that the test medicine has a radioactive component which helps us to track where the test medicine is in the body. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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