Oral Bioavailability of Solid Formulation of GLPG1837 With and Without Food

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: 500 mg GLPG1837 as oral suspension; Drug: 500 mg GLPG1837 as oral tablet

• Registration Number: NCT02562859
• Lead Sponsor: Galapagos NV

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-23
• Study First Submitted QC: 2015-09-27
• Study First Posted: 2015-09-29
• Status Verified: 2015-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-21
• Last Update Posted: 2015-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GLPG1837 as oral suspension fasted	500 mg GLPG1837 as oral suspension	Single dose of 500 mg GLPG1837 as oral suspension after an overnight fast
GLPG1837 as oral tablet fasted	500 mg GLPG1837 as oral tablet	Single dose of 500 mg GLPG1837 as oral tablet after an overnight fast
GLPG1837 as oral tablet fed	500 mg GLPG1837 as oral tablet	Single dose of 500 mg GLPG1837 as oral tablet after a high-fat high-calorie breakfast

Primary Outcome Measures

Name	Time	Method
The maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma	Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)	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
The concentration observed at 24 hours post dose (C24h) of GLPG1837 (metabolite) in plasma	Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 2 (24h post dose) in period 3 (last dose of GLPG1837)	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
The time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma	Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)	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
The area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma	Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)	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
The apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma	Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)	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
The metabolite over GLPG1837 ratios in plasma	Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)	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

Secondary Outcome Measures

Name	Time	Method
Changes in urine safety lab parameters	Between Screening and 7 to 10 days after the last dose of GLPG1837	To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in urine safety lab parameters reported
Number of adverse events	Between Screening and 7 to 10 days after the last dose of GLPG1837	To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of number of adverse events (AEs) reported
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	To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in vital signs as measured by heart rate, blood pressure and oral body temperature reported
Changes in 12-lead ECG measures	Between Screening and 7 to 10 days after the last dose of GLPG1837	To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in 12-ECG measures reported
Changes in physical exam measures	Between Screening and 7 to 10 days after the last dose of GLPG1837	To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in physical examination reported
Changes in blood safety lab parameters	Between Screening and 7 to 10 days after the last dose of GLPG1837	To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in blood safety lab parameters reported

Trial Locations

Locations (1)

SGS LSS Clinical Pharmacology Unit Antwerp; 🇧🇪 Antwerp, Belgium