Pharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis.

Phase 1

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: GLPG3067 single dose

• Registration Number: NCT03589313
• Lead Sponsor: Galapagos NV

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-12
• Primary Completion: 2018-03-26
• Study Completion: 2018-03-26
• Status Verified: 2018-07
• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-07-09
• Last Update Submitted: 2018-07-09
• Study First Posted: 2018-07-17
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GLPG3067 single dose.	GLPG3067 single dose	Single Dose of GLPG3067 film coated tablets.

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration-time curve from time zero until 24 hours post-dose ( (AUC0-24h) of GLPG3067 single dose.	Between Day 1 pre-dose and Day 4.	To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
Maximum observed plasma concentration (cmax) of GLPG3067 single dose.	Between Day 1 pre-dose and Day 4.	To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
Area under the plasma concentration-time curve from time zero until 72 hours post-dose (AUC0-72h) of GLPG3067 single dose.	Between Day 1 pre-dose and Day 4.	To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.

Secondary Outcome Measures

Name	Time	Method
The number of subjects with adverse events.	From screening to 19 days after the last dose.	To evaluate the safety and tolerability of a single oral dose of GLPG3067 in adult male subjects with CF.

Trial Locations

Locations (1)

University Hospital Leuven,Pediatric Pulmonology; 🇧🇪 Leuven, Belgium