Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis

Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG2737 Administered as Oral Suspension in Male Subjects With Cystic Fibrosis

This is a single dose, open label study in adult male subjects with cystic fibrosis to investigate the pharmacokinetics, safety and tolerability of GLPG2737.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Drug: GLPG2737 single dose

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • UZ KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GLPG2737 single dose.; Single dose of GLPG2737 oral suspension.	Drug: GLPG2737 single dose; GLPG2737 oral suspension, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma concentration (Cmax) of GLPG2737and its metabolite.	To characterize the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.	Between day 1 pre-dose and 48 hours post-dose.
Time of occurrence of Cmax for GLPG2737(tmax)	To determine PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects.	Between day 1 pre-dose and 48 hours post-dose.
Plasma concentration observed at 24 hours post-dos (C24h)	To assess PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects.	Between day 1 pre-dose and 48 hours post-dose.
Area under the plasma concentration-time curve for GLPG2737 (AUC0-24h)	To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.	Between day 1 pre-dose and 48 hours post-dose.
Area under the plasma concentration-time curve from time zero until 48 hours post-dose (AUC0-48h)	To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.	Between day 1 pre-dose and 48 hours post-dose.
Terminal plasma elimination rate constant (ke)	To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.	Between day 1 pre-dose and 48 hours post-dose.
Apparent terminal elimination half-life ( t1/2)	To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.	Between day 1 pre-dose and 48 hours post-dose.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with adverse events.	To determine the safety and tolerability of GLPG2737 after a single oral dose in CF subjects.	Between screening and 15 days post-dose

Collaborators and Investigators

• Sponsor: Galapagos NV

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2017
• Primary Completion (Actual): August 16, 2017
• Study Completion (Actual): August 16, 2017

Study Registration Dates

• First Submitted: February 23, 2018
• First Submitted That Met QC Criteria: February 23, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Actual): March 19, 2018
• Last Update Submitted That Met QC Criteria: March 15, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: GLPG2737-CL-104; 2017-000449-38 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No