Status:
COMPLETED
Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis
Lead Sponsor:
Galapagos NV
Conditions:
Cystic Fibrosis
Eligibility:
MALE
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2017
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03450720
Start Date
June 28 2017
End Date
August 16 2017
Last Update
March 19 2018
Active Locations (1)
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1
UZ KU Leuven
Leuven, Belgium