NCT03450720

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
Last Updated

March 19, 2018

Status Verified

March 1, 2018

Enrollment Period

2 months

First QC Date

February 23, 2018

Last Update Submit

March 15, 2018

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (7)

  • 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.

    Between day 1 pre-dose and 48 hours post-dose.

  • 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.

    Between day 1 pre-dose and 48 hours post-dose.

  • 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.

    Between day 1 pre-dose and 48 hours post-dose.

  • 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.

    Between day 1 pre-dose and 48 hours post-dose.

  • 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.

    Between day 1 pre-dose and 48 hours post-dose.

  • Terminal plasma elimination rate constant (ke)

    To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.

    Between day 1 pre-dose and 48 hours post-dose.

  • Apparent terminal elimination half-life ( t1/2)

    To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.

    Between day 1 pre-dose and 48 hours post-dose.

Secondary Outcomes (1)

  • Number of subjects with adverse events.

    Between screening and 15 days post-dose

Study Arms (1)

GLPG2737 single dose.

EXPERIMENTAL

Single dose of GLPG2737 oral suspension.

Drug: GLPG2737 single dose

Interventions

GLPG2737 single doseDRUG

GLPG2737 oral suspension, single dose

GLPG2737 single dose.

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ KU Leuven

Leuven, Belgium

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Olivier Van de Steen, MD MBA

    Galapagos NV

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 1, 2018

Study Start

June 28, 2017

Primary Completion

August 16, 2017

Study Completion

August 16, 2017

Last Updated

March 19, 2018

Record last verified: 2018-03

Locations

BE(1)