Cystic Fibrosis
Conditions
Brief summary
This is a single dose, open label study in adult male subjects with cystic fibrosis to investigate the pharmacokinetics, safety and tolerability of GLPG2737.
Interventions
GLPG2737 oral suspension, single dose
Sponsors
Galapagos NV
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparent terminal elimination half-life ( t1/2) | Between day 1 pre-dose and 48 hours post-dose. | To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects. |
| Maximum observed plasma concentration (Cmax) of GLPG2737and its metabolite. | Between day 1 pre-dose and 48 hours post-dose. | To characterize the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects. |
| Time of occurrence of Cmax for GLPG2737(tmax) | Between day 1 pre-dose and 48 hours post-dose. | To determine PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects. |
| Plasma concentration observed at 24 hours post-dos (C24h) | Between day 1 pre-dose and 48 hours post-dose. | To assess PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects. |
| Area under the plasma concentration-time curve for GLPG2737 (AUC0-24h) | Between day 1 pre-dose and 48 hours post-dose. | To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects. |
| Area under the plasma concentration-time curve from time zero until 48 hours post-dose (AUC0-48h) | Between day 1 pre-dose and 48 hours post-dose. | To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects. |
| Terminal plasma elimination rate constant (ke) | Between day 1 pre-dose and 48 hours post-dose. | To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with adverse events. | Between screening and 15 days post-dose | To determine the safety and tolerability of GLPG2737 after a single oral dose in CF subjects. |
Countries
Belgium
Outcome results
None listed