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GLPG1690 600 mg QD

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

Ensayo de Lakefront Biotherapeutics NV en Fibrosis pulmonar idiopatica.

Más ensayos de: Fibrosis pulmonar idiopática.

Fase

Fase 2

Estado

Completado

Participantes

23

previstos

Centros

8

Fin del objetivo primario

may 2017

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en mar 2016.

Qué mide

Number of Patients With Treatment-Emergent Adverse Events (AEs) (From screening up to Day 98) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroA 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).

Más ensayos de LKFT

Todos los de LKFT, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02738801), actualizada en oct 2020.