Pharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis.

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG3067 Administered as Solid Formulation in Male Subjects With Cystic Fibrosis.

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Drug: GLPG3067 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 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.

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: GLPG3067 single dose.<br>Single Dose of GLPG3067 film coated tablets. | Drug: GLPG3067 single dose<br>* GLPG3067 film coated tablets provided at Day 1.<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 GLPG3067 single dose. | To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067. | Between Day 1 pre-dose and Day 4. | 
| Area under the plasma concentration-time curve from time zero until 24 hours post-dose ( (AUC0-24h) of GLPG3067 single dose. | To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067. | Between Day 1 pre-dose and Day 4. | 
| Area under the plasma concentration-time curve from time zero until 72 hours post-dose (AUC0-72h) of GLPG3067 single dose. | To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067. | Between Day 1 pre-dose and Day 4. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects with adverse events. | To evaluate the safety and tolerability of a single oral dose of GLPG3067 in adult male subjects with CF. | From screening to 19 days after the last dose. |