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History of Changes for Study: NCT03450720
Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis.
Latest version (submitted March 15, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 23, 2018 None (earliest Version on record)
2 March 15, 2018 Study Status, Study Identification and Study Description
Comparison Format:

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Study NCT03450720
Submitted Date:  February 23, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: GLPG2737-CL-104
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.
Secondary IDs: 2017-000449-38 [EudraCT Number]
Open or close this module Study Status
Record Verification: February 2018
Overall Status: Completed
Study Start: June 28, 2017
Primary Completion: August 16, 2017 [Actual]
Study Completion: August 16, 2017 [Actual]
First Submitted: February 23, 2018
First Submitted that
Met QC Criteria:
February 23, 2018
First Posted: March 1, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
February 23, 2018
Last Update Posted: March 1, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Galapagos NV
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This is a single dose, open label study in adult male subjects with cystic fibrosis to investigate the PK, safety and tolerability of GLPG2737.
Detailed Description:
Open or close this module Conditions
Conditions: Cystic Fibrosis
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 6 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: GLPG2737 single dose.
Single dose of GLPG2737 oral suspension.
Drug: GLPG2737 single dose
GLPG2737 oral suspension, single dose
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Maximum observed plasma concentration (Cmax) of GLPG2737and its metabolite.
[ Time Frame: Between day 1 pre-dose and 48 hours post-dose. ]

To characterize the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
2. Time of occurrence of Cmax for GLPG2737(tmax)
[ Time Frame: Between day 1 pre-dose and 48 hours post-dose. ]

To determine PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects.
3. Plasma concentration observed at 24 hours post-dos (C24h)
[ Time Frame: Between day 1 pre-dose and 48 hours post-dose. ]

To assess PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects.
4. Area under the plasma concentration-time curve for GLPG2737 (AUC0-24h)
[ Time Frame: Between day 1 pre-dose and 48 hours post-dose. ]

To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
5. Area under the plasma concentration-time curve from time zero until 48 hours post-dose (AUC0-48h)
[ Time Frame: Between day 1 pre-dose and 48 hours post-dose. ]

To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
6. Terminal plasma elimination rate constant (ke)
[ Time Frame: Between day 1 pre-dose and 48 hours post-dose. ]

To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
7. Apparent terminal elimination half-life ( t1/2)
[ Time Frame: Between day 1 pre-dose and 48 hours post-dose. ]

To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
Secondary Outcome Measures:
1. Number of subjects with adverse events.
[ Time Frame: Between screening and 15 days post-dose ]

To determine the safety and tolerability of GLPG2737 after a single oral dose in CF subjects.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Male
Gender Based: Yes
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Study Officials: Olivier Van de Steen, MD MBA
Study Director
Galapagos NV
Locations: Belgium
UZ KU Leuven
Leuven, Belgium
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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