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Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03450720
Recruitment Status : Completed
First Posted : March 1, 2018
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Tracking Information
First Submitted Date  ICMJE February 23, 2018
First Posted Date  ICMJE March 1, 2018
Last Update Posted Date March 19, 2018
Actual Study Start Date  ICMJE June 28, 2017
Actual Primary Completion Date August 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis
Official Title  ICMJE Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG2737 Administered as Oral Suspension in Male Subjects With Cystic Fibrosis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE Drug: GLPG2737 single dose
GLPG2737 oral suspension, single dose
Study Arms  ICMJE Experimental: GLPG2737 single dose.
Single dose of GLPG2737 oral suspension.
Intervention: Drug: GLPG2737 single dose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2018)
6
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 16, 2017
Actual Primary Completion Date August 16, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03450720
Other Study ID Numbers  ICMJE GLPG2737-CL-104
2017-000449-38 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Galapagos NV
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Galapagos NV
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Olivier Van de Steen, MD MBA Galapagos NV
PRS Account Galapagos NV
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP