Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis

Galapagos

Status and phase

Completed

Phase 1

Conditions

Cystic Fibrosis

Treatments

Drug: GLPG2737 single dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT03450720

GLPG2737-CL-104

2017-000449-38 (EudraCT Number)

Details and patient eligibility

About

This is a single dose, open label study in adult male subjects with cystic fibrosis to investigate the pharmacokinetics, safety and tolerability of GLPG2737.

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 informed consent form (ICF).
A confirmed clinical diagnosis of CF.
Two mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene belonging to class I and/or class II and/or class III (documented in the subject's medical record or CF registry).
Weight ≥40 kg.
Exocrine pancreatic insufficiency (documented in the subject's medical record).
Stable concomitant medication regimen for at least 2 weeks prior to study drug administration.
Forced expiratory volume in one second (FEV1) ≥40% of predicted normal for age, gender and height at screening (pre- or postbronchodilator).

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.
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.