Pharmacokinetics/Pharmacodynamics (PK/PD) of Multiple Oral Doses of GLPG0555 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and to evaluate the relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions of GLPG0555 administered for 3 days. Finally, it is aimed to characterize PK and pharmacodynamics (PD) of GLPG0555 after multiple oral administrations.

Official Title
-----------------
Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Oral Doses of GLPG0555 in Healthy Subjects.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: GLPG0555
* Drug: GLPG0555 aqueous
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male, age 18-50 years BMI between 18-30 kg/m², inclusive. Exclusion Criteria: significantly abnormal platelet function or coagulopathy smoking drug or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aqueous formulations for formulation selection<br>50 mg once daily for 3 days of two different aqueous suspensions, with four day wash-out between formulation | Drug: GLPG0555<br>* two different aqueous formulations<br>|
| Experimental: GLPG0555 ascending doses<br>multiple ascending doses for 13 days, ranging from 100 mg once daily upto a maximum to be determined during escalation (given as once or twice daily) | Drug: GLPG0555 aqueous<br>* multiple dose, aqueous formulation, 13 days, 100 mg/day once daily, maximum dose to be determined<br>|
| Placebo Comparator: 3<br>once or twice daily for 13 days, matching the scheme of the multiple ascending dose. | Drug: placebo<br>* multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of multiple dosing |  | Daily during treatment, up to 10 days postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of repeated doses |  | 24 hours postdose | 
| Pharmacodynamics (PD) of GLPG0555 after repeated oral administration |  | up to 10 days postdose | 
| The relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions administered for three days |  | up to 24 hours postdose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Tolerability, Pharmacokinetics