NCT02562859

Brief Summary

The purpose of the study is to evaluate the amount of GLPG1837 and metabolite present in the blood (relative bioavailability) after a single oral administration of 500 mg GLPG1837 given as an oral suspension under fasted conditions as well as a tablet formulation under fasted and fed conditions, in male healthy subjects. Also, the safety and tolerability of a single oral dose of 500 mg GLPG1837 given as an oral suspension under fasted conditions as well as a tablet formulation under fasted and fed conditions, will be assessed. Twelve subjects will receive GLPG1837 on 3 occasions as single dose administrations: as an oral suspension fasted, as an oral tablet, fed and fasted. Treatment administrations will be separated by a wash-out period of at least 6 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_1 healthy

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

September 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 23, 2015

Status Verified

October 1, 2015

Enrollment Period

1 month

First QC Date

September 23, 2015

Last Update Submit

October 21, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

  • The maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma

    To characterize and compare the maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition

    Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)

  • The concentration observed at 24 hours post dose (C24h) of GLPG1837 (metabolite) in plasma

    To characterize and compare the concentration observed at 24 hours post dose (C24h) of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition

    Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 2 (24h post dose) in period 3 (last dose of GLPG1837)

  • The time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma

    To characterize and compare the time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition

    Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)

  • The area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma

    To characterize and compare the area under the plasma concentration versus time curve of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition

    Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)

  • The apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma

    To characterize and compare the apparent terminal half-life of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition

    Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)

  • The metabolite over GLPG1837 ratios in plasma

    To characterize and compare the metabolite over GLPG1837 ratios in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition

    Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)

Secondary Outcomes (6)

  • Number of adverse events

    Between Screening and 7 to 10 days after the last dose of GLPG1837

  • Changes in vital signs as measured by heart rate, blood pressure and oral body temperature

    Between Screening and 7 to 10 days after the last dose of GLPG1837

  • Changes in 12-lead ECG measures

    Between Screening and 7 to 10 days after the last dose of GLPG1837

  • Changes in physical exam measures

    Between Screening and 7 to 10 days after the last dose of GLPG1837

  • Changes in blood safety lab parameters

    Between Screening and 7 to 10 days after the last dose of GLPG1837

  • +1 more secondary outcomes

Study Arms (3)

GLPG1837 as oral suspension fasted

EXPERIMENTAL

Single dose of 500 mg GLPG1837 as oral suspension after an overnight fast

Drug: 500 mg GLPG1837 as oral suspension

GLPG1837 as oral tablet fasted

EXPERIMENTAL

Single dose of 500 mg GLPG1837 as oral tablet after an overnight fast

Drug: 500 mg GLPG1837 as oral tablet

GLPG1837 as oral tablet fed

EXPERIMENTAL

Single dose of 500 mg GLPG1837 as oral tablet after a high-fat high-calorie breakfast

Drug: 500 mg GLPG1837 as oral tablet

Interventions

500 mg GLPG1837 as oral suspensionDRUG

A single dose of 500 mg GLPG1837 administered as oral suspension

GLPG1837 as oral suspension fasted
500 mg GLPG1837 as oral tabletDRUG

A single dose of 500 mg GLPG1837 administered as oral tablet

GLPG1837 as oral tablet fastedGLPG1837 as oral tablet fed

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male, age 18-50 years
  • BMI between 18-30 kg/m2

You may not qualify if:

  • Any condition that might interfere with the procedures or tests in this study
  • Drug or alcohol abuse
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SGS LSS Clinical Pharmacology Unit Antwerp

Antwerp, Antwerp, Belgium

Location

MeSH Terms

Interventions

GLPG1837SuspensionsTablets

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Frédéric Vanhoutte, MD

    Galapagos NV

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2015

First Posted

September 29, 2015

Study Start

September 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 23, 2015

Record last verified: 2015-10

Locations

BE(1)