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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

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: GLPG2737 single dose Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 28, 2017
Actual Primary Completion Date : August 16, 2017
Actual Study Completion Date : August 16, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: GLPG2737 single dose.
Single dose of GLPG2737 oral suspension.
Drug: GLPG2737 single dose
GLPG2737 oral suspension, single dose




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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450720


Locations
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Belgium
UZ KU Leuven
Leuven, Belgium
Sponsors and Collaborators
Galapagos NV
Investigators
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Study Director: Olivier Van de Steen, MD MBA Galapagos NV
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Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03450720    
Other Study ID Numbers: GLPG2737-CL-104
2017-000449-38 ( EudraCT Number )
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases