Oral Bioavailability of Solid Formulation of GLPG1837 With and Without Food

Healthy Clinical Trial

Official title:

An Open-label Study to Compare the Oral Bioavailability of an Oral Tablet of GLPG1837 Relative to an Oral Suspension After Single-dose Intake in Healthy Subjects and to Evaluate the Effect of Food on the Oral Tablet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562859
• Other study ID #: GLPG1837-CL-103
• Secondary ID: 2015-002518-55
• Status: Completed
• Phase: Phase 1
• First received: September 23, 2015
• Last updated: October 21, 2015
• Start date: September 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 500 mg GLPG1837 as oral suspension
A single dose of 500 mg GLPG1837 administered as oral suspension
• 500 mg GLPG1837 as oral tablet
A single dose of 500 mg GLPG1837 administered as oral tablet

Locations

Country	Name	City	State
Belgium	SGS LSS Clinical Pharmacology Unit Antwerp	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	Number of adverse events	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	Between Screening and 7 to 10 days after the last dose of GLPG1837	Yes
Secondary	Changes in vital signs as measured by heart rate, blood pressure and oral body temperature	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	Between Screening and 7 to 10 days after the last dose of GLPG1837	Yes
Secondary	Changes in 12-lead ECG measures	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	Between Screening and 7 to 10 days after the last dose of GLPG1837	Yes
Secondary	Changes in physical exam measures	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	Between Screening and 7 to 10 days after the last dose of GLPG1837	Yes
Secondary	Changes in blood safety lab parameters	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	Between Screening and 7 to 10 days after the last dose of GLPG1837	Yes
Secondary	Changes in urine safety lab parameters	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	Between Screening and 7 to 10 days after the last dose of GLPG1837	Yes