Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis

NCT ID: NCT03450720

Last Updated: 2018-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-28
• Study Completion Date: 2017-08-16

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GLPG2737 single dose.

Single dose of GLPG2737 oral suspension.

Group Type: EXPERIMENTAL

GLPG2737 single dose

Intervention Type: DRUG

GLPG2737 oral suspension, single dose

Interventions

GLPG2737 single dose

GLPG2737 oral suspension, single dose

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier Van de Steen, MD MBA

Role: STUDY_DIRECTOR

Galapagos NV

Locations

UZ KU Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

2017-000449-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG2737-CL-104

Identifier Type: -

Identifier Source: org_study_id