Oral Bioavailability of Solid Formulation of GLPG1837 With and Without Food

NCT ID: NCT02562859

Last Updated: 2015-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2015-10-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GLPG1837 as oral suspension fasted

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

Group Type: EXPERIMENTAL

500 mg GLPG1837 as oral suspension

Intervention Type: DRUG

A single dose of 500 mg GLPG1837 administered as oral suspension

GLPG1837 as oral tablet fasted

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

Group Type: EXPERIMENTAL

500 mg GLPG1837 as oral tablet

Intervention Type: DRUG

A single dose of 500 mg GLPG1837 administered as oral tablet

GLPG1837 as oral tablet fed

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

Group Type: EXPERIMENTAL

500 mg GLPG1837 as oral tablet

Intervention Type: DRUG

A single dose of 500 mg GLPG1837 administered as oral tablet

Interventions

500 mg GLPG1837 as oral suspension

A single dose of 500 mg GLPG1837 administered as oral suspension

Intervention Type: DRUG

500 mg GLPG1837 as oral tablet

A single dose of 500 mg GLPG1837 administered as oral tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric Vanhoutte, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

SGS LSS Clinical Pharmacology Unit Antwerp

Antwerp, Antwerp, Belgium

Countries

Belgium

Other Identifiers

2015-002518-55

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG1837-CL-103

Identifier Type: -

Identifier Source: org_study_id