First-in-Human Single Ascending and Multiple Dose of GLPG0555

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: placebo; Drug: GLPG0555

Study type: Interventional

Funder types: Industry

Identifiers

NCT01023321

GLPG0555-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 GLPG0555 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG555 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Enrollment: 35 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

35 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

single ascending doses

Treatment:

Drug: GLPG0555

Drug: GLPG0555

2

Placebo Comparator group

Description:

single dose placebo

Treatment:

Drug: placebo

Drug: placebo

3

Experimental group

Description:

multiple dose, 7 or 14 days, oral solution

Treatment:

Drug: GLPG0555

Drug: GLPG0555

4

Placebo Comparator group

Description:

multiple dose, 7 or 14 days, oral solution

Treatment:

Drug: placebo

Drug: placebo