First-in-Human Single Ascending and Multiple Dose of GLPG0778

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral doses of GLPG0778 compared to placebo (with and without food). Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Official Title
-----------------
Double-blind, Placebo-controlled, Dose-ranging Trial for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending Oral Doses, and Multiple Oral Doses of GLPG0778 in Healthy Subjects.

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

Intervention / Treatment
-----------------
* Drug: GLPG0778
* Drug: placebo
* Drug: GLPG0778
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male body mass index (BMI) between 18-30 kg/m², inclusive. Exclusion Criteria: any condition that might interfere with the procedures or tests in the study 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: 1<br>single ascending doses | Drug: GLPG0778<br>* single ascending doses, oral solution (10 to 800 mg/dose) and capsules (100 mg/dose)<br>|
| Placebo Comparator: 2<br>single dose placebo | Drug: placebo<br>* single dose, oral solution or capsule (matching corresponding study medication)<br>|
| Experimental: 3<br>multiple dose, 7 days, capsules (dosing depends on outcome of single-dose part; can be once or twice daily). | Drug: GLPG0778<br>* multiple dose, capsule, 7 days<br>|
| Placebo Comparator: 4<br>multiple dose, capsules, 7 days; scheme to match that of Study Arm 3. | Drug: placebo<br>* multiple dose, capsule, 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of single and multiple dosing | Tests will be performed to assess whether the study drug has any potentially adverse effect (laboratory tests on blood and urine for functioning of organs; cardiovascular testing, i.e. of heart and bloodcirculation). Also, participants will carefully be monitored by medical staff for vital signs, and asked to report any side effect experienced in the course of the study. | up to 10 days postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of single and repeated doses, including effect of food. | Bloodsamples are taken on various timepoints to assess how much of the study drug is taken up in the blood (absorption), how long it stays in the blood (excretion), and whether any breakdown-products of the drug are present (metabolism). | up to 10 days postdose | 

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