Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03450720
• Other study ID #: GLPG2737-CL-104
• Secondary ID: 2017-000449-38
• Status: Completed
• Phase: Phase 1
• First received: February 23, 2018
• Last updated: March 15, 2018
• Start date: June 28, 2017
• Est. completion date: August 16, 2017

Study information

• Verified date: March 2018
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 16, 2017
• Est. primary completion date: August 16, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• GLPG2737 single dose
GLPG2737 oral suspension, single dose

Locations

Country	Name	City	State
Belgium	UZ KU Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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