Pharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis.

• Status: Completed
• Trial end date: 2018-03-26
• Target enrollment: 0
• Participant gender: Male

Summary

This clinical study is a Phase I, open-label, single-center study designed to evaluate the pharmacokinetics profile of a single oral dose of GLPG3067 in adult male subjects with cystic fibrosis in fed state.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galapagos NV

Criteria

Inclusion Criteria:

• Male subject ≥18 years of age on the day of signing the ICF.

• A confirmed clinical diagnosis of CF.

• Exocrine pancreatic insufficiency (documented in the subject's medical record).

• Stable concomitant medication regimen for pulmonary health for at least 2 weeks prior to study drug administration

Exclusion Criteria:

• History of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator.

• Unstable pulmonary status or respiratory tract infection (including rhinosinusitis) requiring a change in therapy within 2 weeks prior to study drug administration.

• Need for supplemental oxygen during the day, and >2 L/minute while sleeping.

• History of solid organ or hematopoietic cell transplantation.

• History of hepatic cirrhosis with portal hypertension (e.g., signs/symptoms of splenomegaly, esophageal varices).

• Use of CFTR modulator therapy (e.g., lumacaftor or ivacaftor) within 2 weeks prior to study drug administration.

• Abnormal liver function test at screening, defined as aspartate aminotransferase (AST) and/or ALT and/or alkaline phosphatase and/or gamma-glutamyl transferase (GGT) ≥3x the upper limit of normal, and/or total bilirubin ≥1.5x the upper limit of normal.