First-in-Human Single Ascending and Multiple Dose of GLPG0259

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GLPG0259; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00905138

GLPG0259-CL-101

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

32 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

single ascending doses

Treatment:

Drug: GLPG0259

Drug: GLPG0259

2

Placebo Comparator group

Description:

single dose placebo

Treatment:

Drug: placebo

Drug: placebo

3

Experimental group

Description:

multiple dose, 5 days, oral solution

Treatment:

Drug: GLPG0259

Drug: GLPG0259

4

Placebo Comparator group

Description:

multiple dose, 5 days, oral solution

Treatment:

Drug: placebo

Drug: placebo