Pharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis.

Galapagos

Status and phase

Completed

Phase 1

Conditions

Cystic Fibrosis

Treatments

Drug: GLPG3067 single dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT03589313

GLPG3067-CL-104

2017-002294-19 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.