Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis

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

Official Title
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Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG2737 Administered as Oral Suspension in Male Subjects With Cystic Fibrosis

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Drug: GLPG2737 single dose


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLPG2737 single dose.<br>Single dose of GLPG2737 oral suspension. | Drug: GLPG2737 single dose<br>* GLPG2737 oral suspension, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of GLPG2737and its metabolite. | To characterize the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects. | Between day 1 pre-dose and 48 hours post-dose. | 
| Time of occurrence of Cmax for GLPG2737(tmax) | To determine PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects. | Between day 1 pre-dose and 48 hours post-dose. | 
| Plasma concentration observed at 24 hours post-dos (C24h) | To assess PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects. | Between day 1 pre-dose and 48 hours post-dose. | 
| Area under the plasma concentration-time curve for GLPG2737 (AUC0-24h) | To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects. | Between day 1 pre-dose and 48 hours post-dose. | 
| Area under the plasma concentration-time curve from time zero until 48 hours post-dose (AUC0-48h) | To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects. | Between day 1 pre-dose and 48 hours post-dose. | 
| Terminal plasma elimination rate constant (ke) | To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects. | Between day 1 pre-dose and 48 hours post-dose. | 
| Apparent terminal elimination half-life ( t1/2) | To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects. | Between day 1 pre-dose and 48 hours post-dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events. | To determine the safety and tolerability of GLPG2737 after a single oral dose in CF subjects. | Between screening and 15 days post-dose |