Clinical trial NCT03450720: Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis
Official title: Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG2737 Administered as Oral Suspension in Male Subjects With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2018-03-01
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of GLPG2737and its metabolite.
timeFrame: Between day 1 pre-dose and 48 hours post-dose.
measure: Time of occurrence of Cmax for GLPG2737(tmax)
timeFrame: Between day 1 pre-dose and 48 hours post-dose.
measure: Plasma concentration observed at 24 hours post-dos (C24h)
timeFrame: Between day 1 pre-dose and 48 hours post-dose.
measure: Area under the plasma concentration-time curve for GLPG2737 (AUC0-24h)
timeFrame: Between day 1 pre-dose and 48 hours post-dose.
measure: Area under the plasma concentration-time curve from time zero until 48 hours post-dose (AUC0-48h)
timeFrame: Between day 1 pre-dose and 48 hours post-dose.
measure: Terminal plasma elimination rate constant (ke)
timeFrame: Between day 1 pre-dose and 48 hours post-dose.
measure: Apparent terminal elimination half-life ( t1/2)
timeFrame: Between day 1 pre-dose and 48 hours post-dose.
Secondary outcomes:
measure: Number of subjects with adverse events.
timeFrame: Between screening and 15 days post-dose
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ KU Leuven
Study officials:
affiliation: Galapagos NV
name: Olivier Van de Steen, MD MBA
role: STUDY_DIRECTOR
References: