Oral Bioavailability of Solid Formulation of GLPG1837 With and Without Food

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 500 mg GLPG1837 as oral tablet; Drug: 500 mg GLPG1837 as oral suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT02562859

2015-002518-55 (EudraCT Number)

GLPG1837-CL-103

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

GLPG1837 as oral suspension fasted

Experimental group

Description:

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

Treatment:

Drug: 500 mg GLPG1837 as oral suspension

GLPG1837 as oral tablet fasted

Experimental group

Description:

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

Treatment:

Drug: 500 mg GLPG1837 as oral tablet

GLPG1837 as oral tablet fed

Experimental group

Description:

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

Treatment:

Drug: 500 mg GLPG1837 as oral tablet