Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis

Lakefront Biotherapeutics NV6 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

GLPG2737 single doseDRUG

GLPG2737 oral suspension, single dose

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

UZ KU Leuven

Leuven, Belgium