Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis

Phase 1

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: GLPG2737 single dose

• Registration Number: NCT03450720
• Lead Sponsor: Galapagos NV

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-28
• Primary Completion: 2017-08-16
• Study Completion: 2017-08-16
• Study First Submitted: 2018-02-23
• Study First Submitted QC: 2018-02-23
• Status Verified: 2018-03
• Study First Posted: 2018-03-01
• Last Update Submitted: 2018-03-15
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

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

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).

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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.
• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GLPG2737 single dose.	GLPG2737 single dose	Single dose of GLPG2737 oral suspension.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

UZ KU Leuven; 🇧🇪 Leuven, Belgium