Back to resultsPharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis.
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
GLPG3067 single dose
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis
Eligibility Criteria
Inclusion Criteria:
- Male subject ≥18 years of age on the day of signing the ICF.
- A confirmed clinical diagnosis of CF.
- Exocrine pancreatic insufficiency (documented in the subject's medical record).
- Stable concomitant medication regimen for pulmonary health for at least 2 weeks prior to study drug administration
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.
- Need for supplemental oxygen during the day, and >2 L/minute while sleeping.
- History of solid organ or hematopoietic cell transplantation.
- 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.
- Abnormal liver function test at screening, defined as aspartate aminotransferase (AST) and/or ALT and/or alkaline phosphatase and/or gamma-glutamyl transferase (GGT) ≥3x the upper limit of normal, and/or total bilirubin ≥1.5x the upper limit of normal.
Sites / Locations
- University Hospital Leuven,Pediatric Pulmonology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GLPG3067 single dose.
Arm Description
Single Dose of GLPG3067 film coated tablets.
Outcomes
Primary Outcome Measures
Maximum observed plasma concentration (cmax) of GLPG3067 single dose.
To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
Area under the plasma concentration-time curve from time zero until 24 hours post-dose ( (AUC0-24h) of GLPG3067 single dose.
To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
Area under the plasma concentration-time curve from time zero until 72 hours post-dose (AUC0-72h) of GLPG3067 single dose.
To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
Secondary Outcome Measures
The number of subjects with adverse events.
To evaluate the safety and tolerability of a single oral dose of GLPG3067 in adult male subjects with CF.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03589313
Brief Title
Pharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis.
Official Title
Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG3067 Administered as Solid Formulation in Male Subjects With Cystic Fibrosis.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
March 26, 2018 (Actual)
Study Completion Date
March 26, 2018 (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
5. Study Description
Brief Summary
This clinical study is a Phase I, open-label, single-center study designed to evaluate the pharmacokinetics profile of a single oral dose of GLPG3067 in adult male subjects with cystic fibrosis in fed state.
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
GLPG3067 single dose.
Arm Type
Experimental
Arm Description
Single Dose of GLPG3067 film coated tablets.
Intervention Type
Drug
Intervention Name(s)
GLPG3067 single dose
Intervention Description
GLPG3067 film coated tablets provided at Day 1.
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (cmax) of GLPG3067 single dose.
Description
To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
Time Frame
Between Day 1 pre-dose and Day 4.
Title
Area under the plasma concentration-time curve from time zero until 24 hours post-dose ( (AUC0-24h) of GLPG3067 single dose.
Description
To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
Time Frame
Between Day 1 pre-dose and Day 4.
Title
Area under the plasma concentration-time curve from time zero until 72 hours post-dose (AUC0-72h) of GLPG3067 single dose.
Description
To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
Time Frame
Between Day 1 pre-dose and Day 4.
Secondary Outcome Measure Information:
Title
The number of subjects with adverse events.
Description
To evaluate the safety and tolerability of a single oral dose of GLPG3067 in adult male subjects with CF.
Time Frame
From screening to 19 days after the last 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 ICF.
A confirmed clinical diagnosis of CF.
Exocrine pancreatic insufficiency (documented in the subject's medical record).
Stable concomitant medication regimen for pulmonary health for at least 2 weeks prior to study drug administration
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.
Need for supplemental oxygen during the day, and >2 L/minute while sleeping.
History of solid organ or hematopoietic cell transplantation.
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.
Abnormal liver function test at screening, defined as aspartate aminotransferase (AST) and/or ALT and/or alkaline phosphatase and/or gamma-glutamyl transferase (GGT) ≥3x the upper limit of normal, and/or total bilirubin ≥1.5x the upper limit of normal.
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
University Hospital Leuven,Pediatric Pulmonology
City
Leuven
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis.
We'll reach out to this number within 24 hrs