First-in-Human Single Ascending Dose of GLPG0492

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) oral dose of GLPG0492 compared to placebo in healthy subjects. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after single oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined. Oral bioavailability (solution vs solid capsule fasting or fed) is evaluated in healthy elderly subjects.

Official Title
-----------------
Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of GLPG0492 in Healthy Subjects and Open Relative Bioavailability Study of Oral Solution Versus Solid Formulation, Fasted and Fed, in Elderly Subjects

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

Intervention / Treatment
-----------------
* Drug: GLPG0492
* Drug: placebo
* Drug: GLPG0492
* Drug: GLPG0492


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male, age 18-50 years (young subjects) OR ≥60 years (elderly subjects) BMI between 18-30 kg/m², inclusive non-smoker Exclusion Criteria: elevated PSA drug or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 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: GLPG0492<br>* single ascending doses, oral solution (25 to max. 120 mg/intake, 10 to 200 mg/mL)<br>|
| Placebo Comparator: 2<br>single dose placebo | Drug: placebo<br>* single dose, oral solution<br>|
| Experimental: 3<br>single dose, oral solution, 50 mg | Drug: GLPG0492<br>* single ascending doses, oral solution (25 to max. 120 mg/intake, 10 to 200 mg/mL)<br>|
| Experimental: 4<br>single dose, capsules (fasting) | Drug: GLPG0492<br>* single dose, solid formulation, 50 mg (2*25 mg/capsule), fasting<br>|
| Experimental: 5<br>single dose, capsules (fed) | Drug: GLPG0492<br>* single dose, solid formulation, 50 mg (2*25 mg/capsule), after high fat breakfast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of single ascending doses in healthy young and elderly subjects. |  | up to 10 days postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of single oral doses (solution) in young and elderly subjects. |  | up to 10 days postdose | 
| Determine oral bioavailability of GLPG0492 given to elderly subjects as oral solution or solid dosage form with or without food. |  | up to 10 days postdose | 
| Determine the maximum tolerated dose in young subjects. |  | Up to 10 days postdose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Tolerability, Pharmacokinetics, Bioavailability (solid vs solution, fasting vs fed), Young healthy subjects, Elderly healthy subjects