Clinical trial NCT02562859: Oral Bioavailability of Solid Formulation of GLPG1837 With and Without Food
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2015-09-29
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma
timeFrame: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
measure: The concentration observed at 24 hours post dose (C24h) of GLPG1837 (metabolite) in plasma
timeFrame: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 2 (24h post dose) in period 3 (last dose of GLPG1837)
measure: The time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma
timeFrame: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
measure: The area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma
timeFrame: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
measure: The apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma
timeFrame: Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
measure: The metabolite over GLPG1837 ratios in plasma
timeFrame: 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:
measure: Number of adverse events
timeFrame: Between Screening and 7 to 10 days after the last dose of GLPG1837
measure: Changes in vital signs as measured by heart rate, blood pressure and oral body temperature
timeFrame: Between Screening and 7 to 10 days after the last dose of GLPG1837
measure: Changes in 12-lead ECG measures
timeFrame: Between Screening and 7 to 10 days after the last dose of GLPG1837
measure: Changes in physical exam measures
timeFrame: Between Screening and 7 to 10 days after the last dose of GLPG1837
measure: Changes in blood safety lab parameters
timeFrame: Between Screening and 7 to 10 days after the last dose of GLPG1837
measure: Changes in urine safety lab parameters
timeFrame: Between Screening and 7 to 10 days after the last dose of GLPG1837
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS LSS Clinical Pharmacology Unit Antwerp
Study officials:
affiliation: Galapagos NV
name: Frédéric Vanhoutte, MD
role: STUDY_DIRECTOR
References: