Trial | NCT00905138  Report issue

Title

First-in-Human Single Ascending and Multiple Dose of GLPG0259
Double Blind, Placebo-controlled Trial for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending and Multiple Oral Doses of GLPG0259 in Healthy Subjects

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    glpg-0259 ...

  • Study Participants

    32
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral dose of GLPG0259 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.
Study Started
Mar 31
2009
Primary Completion
Jun 30
2009
Study Completion
Jun 30
2009
Last Update
Feb 20
2012
Estimate

Drug GLPG0259

single ascending doses, oral solution

Drug placebo

single dose, oral solution

Drug GLPG0259

multiple dose, oral solution, 5 days

Drug placebo

oral solution, 5 days

1 Experimental

single ascending doses

2 Placebo Comparator

single dose placebo

3 Experimental

multiple dose, 5 days, oral solution

4 Placebo Comparator

multiple dose, 5 days, oral solution

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
No Results Posted