search
Back to results

Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
GLPG2737 single dose
Sponsored by
Galapagos NV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • UZ KU Leuven

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GLPG2737 single dose.

Arm Description

Single dose of GLPG2737 oral suspension.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
Terminal plasma elimination rate constant (ke)
To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
Apparent terminal elimination half-life ( t1/2)
To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.

Secondary Outcome Measures

Number of subjects with adverse events.
To determine the safety and tolerability of GLPG2737 after a single oral dose in CF subjects.

Full Information

First Posted
February 23, 2018
Last Updated
March 15, 2018
Sponsor
Galapagos NV
search

1. Study Identification

Unique Protocol Identification Number
NCT03450720
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 28, 2017 (Actual)
Primary Completion Date
August 16, 2017 (Actual)
Study Completion Date
August 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galapagos NV

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GLPG2737 single dose.
Arm Type
Experimental
Arm Description
Single dose of GLPG2737 oral suspension.
Intervention Type
Drug
Intervention Name(s)
GLPG2737 single dose
Intervention Description
GLPG2737 oral suspension, single dose
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax) of GLPG2737and its metabolite.
Description
To characterize the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
Time Frame
Between day 1 pre-dose and 48 hours post-dose.
Title
Time of occurrence of Cmax for GLPG2737(tmax)
Description
To determine PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects.
Time Frame
Between day 1 pre-dose and 48 hours post-dose.
Title
Plasma concentration observed at 24 hours post-dos (C24h)
Description
To assess PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects.
Time Frame
Between day 1 pre-dose and 48 hours post-dose.
Title
Area under the plasma concentration-time curve for GLPG2737 (AUC0-24h)
Description
To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
Time Frame
Between day 1 pre-dose and 48 hours post-dose.
Title
Area under the plasma concentration-time curve from time zero until 48 hours post-dose (AUC0-48h)
Description
To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
Time Frame
Between day 1 pre-dose and 48 hours post-dose.
Title
Terminal plasma elimination rate constant (ke)
Description
To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
Time Frame
Between day 1 pre-dose and 48 hours post-dose.
Title
Apparent terminal elimination half-life ( t1/2)
Description
To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
Time Frame
Between day 1 pre-dose and 48 hours post-dose.
Secondary Outcome Measure Information:
Title
Number of subjects with adverse events.
Description
To determine the safety and tolerability of GLPG2737 after a single oral dose in CF subjects.
Time Frame
Between screening and 15 days post-dose

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Van de Steen, MD MBA
Organizational Affiliation
Galapagos NV
Official's Role
Study Director
Facility Information:
Facility Name
UZ KU Leuven
City
Leuven
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis

We'll reach out to this number within 24 hrs